Quality Leader Resume Samples

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B Mante

Brandt

Mante

9945 Guy Parkways

Chicago

+1 (555) 397 0039

9945 Guy Parkways

Chicago

Phone

p +1 (555) 397 0039

Experience Experience

Phoenix, AZ

Quality Leader

Phoenix, AZ

Stark, Towne and Collins

Phoenix, AZ

Quality Leader

Performs call monitoring and provides trend data to management team
Be responsible to create and develop a Quality Management System for the newly built plant
Serve as an active member of the Plant staff to help guide the intermediate and long term improvement of processes relative to KPIs and Development of people
Uses quality monitoring data management system to compile and track performance at team and individual level
Provides Call and email Quality feedback to call center HRMS, team leaders and managers
Participate in discussions with Organizational and Plant management including presentations of strategies, goals, activities, in all areas of responsibility
Ensure departmental created documentation is organized and readily accessible

Chicago, IL

Team Leader Quality

Chicago, IL

Hegmann-Larson

Chicago, IL

Team Leader Quality

Provides technical assistance and training to QA personnel
Create COAs for our products
Works with operations personnel on quality and safety issues
Manage Pest Control Program
Ensures SPC Management practices are followed
Supervise Quality Technicians (non-exempt) on 3 shifts
Review all COAs on incoming ingredients

present

Philadelphia, PA

Opsdata Quality Team Leader

Philadelphia, PA

Brakus, Denesik and Langosh

present

Philadelphia, PA

Opsdata Quality Team Leader

present

The departments are also responsible for establishment of daily operational control processes by tracking, testing,analyzing and reporting of key conditions
Manage planning, operation and problem solving so that team meets its goals and SLA
Responsible for providing core IT Operational support to key functional areas in Santander Operations
Gather information and review processes. Implement new procedures, metrics and targets
Action plans are designed to correct errors that are discovered during such analysis
2+ years exp in accounting, auditing, IT, finance
The department aims to ensure high-level of accuracy in data quality by taking direct ownership of data in the Core IT System

Education Education

Bachelor’s Degree in Engineering

Cornell University

Bachelor’s Degree in Engineering

Skills Skills

Proficiency in MS office i.e. MS Excel, Word & etc
Able to develop solution to a variety of problems solving
Able to effectively make decision in matters of significance to customer experience
Able to effectively communicate with multiple functions within the company and with people of all levels of management
Strong English - written & verbal
Self-motivated & high performer
Experience in managing team and projects
Experience in ISO 9000
Experience working in mechanical manufacturing in automotive or metal stamping/dye casting would be an added advantage

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Senior Quality Leader Resume Examples & Samples

Base knowledge of the W3C’s Web Content Accessibility Guidelines v2.0
Exposure to current tools used by people with disabilities (screen readers and other assistive technologies)
Experience with accessibility evaluation and validation software
Understanding of input and output modes used by people with disabilities
Familiarity with compliance requirements - state, Federal, international

Quality Leader Resume Examples & Samples

Control the quality of inputted constituent materials
Support critical maintenance (reactive, preventive, and predictive) of processing equipment
Utilize expertise to maintain calibration of sensors, gauges, PLC’s and other process equipment to assure ultimate control of end product
Own and drive the quality assurance and quality control for the products and manufacturing processes
Drive preventive and corrective actions to assure product compliance to specifications
Be responsible to create and develop a Quality Management System for the newly built plant
Serve as the site's focal point for Quality with customers, headquarters, and auditors
Conduct recruitment, selection, development, and promotion of the Quality team
Utilize Lean and Six Sigma tools to monitor and drive all process improvement activities
Bachelor's degree from an accredited university or college
Minimum of 5 additional years of experience in Manufacturing or Production Quality
Ability to travel up to 50% in the first year, and up to 30% subsequently
Experience with polymer or chemical manufacturing
Experience with continuous manufacturing and raw material batching
Working understanding of Quality Systems, including in heavily regulated industries
Strong oral and written communication skills
Strong interpersonal and leadership skills
Demonstrated ability to analyze and resolve problems
Demonstrated ability to lead programs / projects
Ability to document, plan, market, and execute programs
Established project management skills

Quality Leader Resume Examples & Samples

Bachelor’s Degree in Mechanical / Industrial / Electrical / Electronics Engineering
Very strong result oriented mindset and leadership qualities
MUST: Highest Level of Integrity
Demonstrated interpersonal and leadership skills
Proven conflict resolution skills
Ability to work independently with high level of accuracy
Ability to communicate with all levels of the organization
Strong analytical and presentation skills
Strong organizational skills and ability to prioritize and balance workload to meet deadlines

RTE Quality Team Leader Resume Examples & Samples

Lead the RTE production quality department for plant
Overall accountability and ownership for Quality of RTE areas
Effective and proactive relationship with USDA
Develop effective and cooperative relationships with all support departments (maintenance, corporate quality, corporate R&D, etc.)

Incoming Quality Team Leader Resume Examples & Samples

Demonstrated leadership qualities and the ability to coach/mentor others
Technically and statistically proficient
Strict adherence to regulatory requirements
Ability to deal with and manage change
JDE/ERP experience a plus
Associates degree required, Bachelor’s degree preferred
Prior supervisory experience in a manufacturing environment

Quality Laboratory Team Leader Resume Examples & Samples

Coordinate the technical laboratories – people, facilities and processes
Communicate quality deviations with requester and support containment actions
Manage Resources according business priorities
Validate technical reports from Lab’s
Assure adequate measurement, calibration and validation procedures: Product, parts and test equipment’s
Set-up Calibration Plan for plant test equipment’s
Set-up Investment Plan for test facilities according business requirements

Guidance & Quality Team Leader Resume Examples & Samples

Managing and supervising the work of a team of advisers and analysts who directly support these processes by working closely with Private Bankers/Private Banker Executives (PBEs), Financial Crime and Operations colleagues
Working closely with these stakeholder areas at a management level to ensure that the team are meeting their expectations and being provided with the required support to deliver the role
Supporting the ongoing development and extension of the processes that the team supports, both through project deliveries via the Wealth KYC Programme and by continuous improvement within the team
Being part of the Onboarding Journeys Management Team and will be expected to contribute to the overall management of the function and the support it provides to the UK Private Bank Business Unit
Developing a good understanding of the business strategy and the team’s contribution to this
Being part of the wider Onboarding Journeys management team, and will be expected to contribute to the wider success of the team by working in partnership with peers and colleagues
Taking on additional responsibilities relating to new client onboarding as the team transitions to a new end state
Being the primary first line of defence for KYC and AML within UK Private Banking – as such they are responsible for setting the direction for meeting these key regulatory objectives and will be key in ensuring that Barclays meets its regulatory obligations in this high-profile and sensitive arena
A comprehensive knowledge of the role of other departments within the end to end process, and how they contribute to the success of the organization
Understanding of the wider industry context will also be required
A proven track record of competent assessment skills utilising information from both internal bank sources and external sources
Being adaptable and possessing the ability to prioritise and manage demanding workloads of themselves and others, including monitoring and predicting workflow and resource requirements
Possessing experience in AML regulations and an understanding and working knowledge of Financial Crime prevention
An appreciation of the role of a private banker are essential, as in an understanding of the Private Bank business and needs of its clients
The ability to make complex judgements and come up with solutions based on detailed analysis and a comparison of complex alternatives, including the ability to define problems and develop innovative solutions
Extensive managerial experience is required for this role although the holder will have the aptitude to be able to develop these skills further
The ability to negotiate and influence senior stakeholders across the business. This would include senior (MD and Director) colleagues across the UK Private Bank, Financial Crime and other related functions The outcome of such negotiations are likely to have a material impact on both commercial and risk outcomes for the UK Private Bank
Possessing effective communication and presentation skills using a variety of styles to suit the situation
A proven track record of working and managing a team to deadlines will be required, together with strong organisational skills and the ability and confidence to make business critical decisions

A-team Leader Quality Resume Examples & Samples

Provide training and leadership to insure that wmployees are performing assigned work properly
Control line flows and blend rates as necessary and directed
Assist with the supervision of sanitation operations as necessary
Enforce rules, regulations and procedures
PQ training completed
Excellent PC skills, to include Windows, Word and Excel

Team Leader Product Development Quality Services Resume Examples & Samples

Developing and deploying SOPs and associated training
Designing and delivering GCP/PV training
Managing systems to support SOP and training deliverables
Supporting GCP/PV inspection readiness and managing inspections end-to-end

Scra Quality Team Leader Resume Examples & Samples

Ability to quickly learn processes and operations to efficiently perform quality control reviews
Demonstrate proficiency in accessing multiple systems, platforms, applications and data sources in various environments
Demonstrate a strong sense of urgency in responding immediately to escalate issues and rapidly changing priorities
Review supporting documentation to ensure Military Processing Specialist followed guidelines and adhered to SCRA (Servicemembers Civil Relief Act) and the JPMorgan Chase Firmwide Policy
Must be organized and have the ability to multi-task
Demonstrated leadership, influencing, and coaching skills
Ability to work independently as well as in a team setting to achieve objectives

Quality Leader Resume Examples & Samples

Ownership includes both quality assurance and quality control
Includes quality assurance of products, services, manufacturing processes
Includes conformance in manufacturing, incoming goods control, product inspection, witness points, etc
Develops research programs on the basis of a year
Gives input to business programs of a encompassing part of a function or a business unit and to midterm plan
Minimum of 5 additional years of experience in Production Quality

Team Leader Quality Resume Examples & Samples

Review all COAs on incoming ingredients
Create COAs for our products
Inventory and order all lab supplies
Manage Pest Control Program
Participate in operational meetings
Supervise Quality Technicians (non-exempt) on 3 shifts

Senior Industrial Quality Leader Resume Examples & Samples

Proficient in English
Quality skills equivalent to a Six Sigma Green Belt
PFMEA and Control Plan execution
Design for Quality/Manufacturing knowledge
GD&T exposure and understanding
Understanding of measurement technologies their application and limitations
Experience with assembly, sheet metal fabrication, stamping, and molding
Working knowledge of Microsoft Word, Excel, PowerPoint, and Project
3 years - Plant level Quality Engineer, Supplier Quality Engineer, or equivalent
New product/process development experience a plus
Bachelor’s degree in Mechanical, Electrical, Industrial, or Manufacturing Engineering preferred

Industrial Quality Leader Resume Examples & Samples

Proficient in English
Quality skills equivalent to a Six Sigma Green Belt
PFMEA and Control Plan execution
Design for Quality/Manufacturing knowledge
GD&T exposure and understanding
Understanding of measurement technologies their application and limitations
Experience with assembly, sheet metal fabrication, stamping, and molding
Working knowledge of Microsoft Word, Excel, PowerPoint, and Project
3 years - Plant level Quality Engineer, Supplier Quality Engineer, or equivalent
New product/process development experience a plus
Bachelor’s degree in Mechanical, Electrical, Industrial, or Manufacturing Engineering preferred

Quality Excellence Leader Resume Examples & Samples

50%
Serve as the SME for process improvement and technical skills development for the segment
Identify the current technical skill level of the segment associates and develop strategies for improvement
Implement best practice sharing, standardization, and process excellence across the segment
Support One Global Quality across all segments
Implement Newell Brands Quality policies and procedures
Support segment specific initiatives that drive process control
Train and Lead OPEX and Lean Six Sigma initiatives
40%
Work collaboratively with the Corporate Quality Excellence Team (Center of Excellence) to implement standard tools and process
Work collaboratively with other functions (SC, Manufacturing, R&D, Marketing, etc.) to drive consumer satisfaction and company objectives through continuous improvement
Participate and/or Lead internal teams (and others) on the skills and techniques to investigate and resolve customer/consumer complaints
10% Work collaboratively with other segments and functions as needed
Perform other duties as assigned or requested
Must be able to coach and communicate effectively with external suppliers/stakeholders and all levels of the organization to negotiate, influence and enforce Quality and Company policies
Bachelor’s degree in engineering, technical engineering or science discipline or combination or equivalent experience
Six Sigma Black Belt or Master Black Belt
Must have 3-5 years of lean six sigma, operations, manufacturing or supplier quality, experience
Ability to execute Quality methods and systems (statistics, reliability, sampling, and auditing, problem solving)
Interpersonal and communication skills are essential for dealing with all levels of internal and external suppliers and customers
Problem solving background
ISO / QS / TS / FDA quality system working knowledge and auditing experience
Microsoft Office software skills including Excel, Word and PowerPoint
Frequent domestic travel expected

Leader, Quality Team Resume Examples & Samples

Leading as Lean & Quality in manufacturing operation/customer experience to develop & execute quality strategies and requirements to ensure provisions for quality are addressed and resolved
Leading governance, coordinate & monitor production process controls to ensure high quality performance on product & customer experience
Provide validation support by applying manufacturing quality tools including, but not limited to: PFMEA, QAS, control plans, process verification/validation plans, Cp-Cpk, SPC and process data analysis
Compile and institute quality metric trending analysis on quality performance KPI
Coordinate investigations & failure analysis of products to reports and analyse risk
Promotes and supports implementation of continuous improvements in manufacturing and associated areas on Safety, Quality, Delivery & Cost
Investigate and resolve client’s complaints that occur in product quality
Self-motivated & high performer
Able to develop solution to a variety of problems solving
Able to effectively make decision in matters of significance to customer experience
Able to effectively communicate with multiple functions within the company and with people of all levels of management
Proficiency in MS office i.e. MS Excel, Word & etc
Strong English - written & verbal
Posses at least Degree level in Engineerings
Minimum certified 6 Sigma- green belt
Experience in managing team and projects
Experience in ISO 9000
Working in Quality & LEAN manufacturing applications with minimum of 5 years experience AND /OR
Working in Six Sigma manufacturing applications with minimum of 5 years experience
Experience working in mechanical manufacturing in automotive or metal stamping/dye casting would be an added advantage
LEAN manufacturing experience is a must

Global Quality Leader Resume Examples & Samples

Develop and implement A&C quality engineering strategy to establish A&C operations as a competitive advantage
Foster an environment conducive to continuous improvement culture for an effective quality management system (QMS) to achieve customer satisfaction, reduce risk and implement Best Demonstrated Practices across all locations
Manage compliance and regulatory quality requirements in line to local/international laws for recalls and warranty claims. Work with finance team closely to manage risks as required
Lead new product development process from quality engineering prospective and utilize advance product quality planning tools to implement quality assurance strategy to meet quality targets
Collaborate with design and manufacturing engineering to drive DFx (DFM, DFT, DFA ) and Poka-Yoke concepts integration during concept and design phases to achieve 6 sigma quality level
Implement robust root cause corrective action and impact process. Mentor cross functions teams to conduct root cause analysis on both internal and external quality issues and formulate resolutions in a timely manner. Also, to ensure the implementation and effectiveness of actions and prevent problem from reoccurring
Lead reductions in total customer complaints and Cost of Poor Quality (CoPQ)
Lead differentiated quality level by PLT (Product Line Teams). Coach; lead and mentor PLT quality leaders
Manage Contract Review on Customer Quality Assurance Requirements. Update quality documentation and communicate to carry forward lessons learned from quality concerns in new customer contracts
Ensure that all necessary systems and procedures are in place to satisfy specific customer requirements and audits
In conjunction with the Supplier Quality Assurance function, reduce the effect of non-conforming supplier materials on the production area quality
Input and hold responsibility for Quality budgets. Develop forward looking quality improvement plans along with plants for capital spending. Prepare justification proposals, document specifications, develop performance requirements and oversee project planning and execution
Report against agreed quality metrics on a weekly, monthly and quarterly basis
Manage, coach and develop a high performing Quality engineering team that meets agreed objectives and which delivers best practice results, added value and continuous improvements
Consistently promote high standards through personal example and roll out through the team so that each member of the team understands the standards and behaviors expected of them
Six Sigma black Belt is preferred
Excellent commercial and business acumen with deep experience in analyzing management trends and capabilities
Experienced in matrix management with a track record of being able to manage by influence and coordinate cross business unit activities
Excellent project and team management skills. Demonstrated ability to manage multiple, sometimes conflicting, priorities and meet aggressive deadlines
Strong advance management skills, including personnel development
BA/BS degree in an Engineering or Technical discipline, advanced engineering degree strongly preferred
Willingness to travel, and as necessary, to support a global organization

Quality Leader Resume Examples & Samples

Participates in design of call monitoring formats and quality standards
Performs call monitoring and provides trend data to management team
Uses quality monitoring data management system to compile and track performance at team and individual level
Monitors emails and telephone customer interactions
Participates in customer and vendor listening programs to identify customer needs, improvement areas on call Quality and expectations
Provides actionable data to various internal support groups as needed
Coordinates and facilitates call calibration sessions for call center staff
Provides Call and email Quality feedback to call center HRMS, team leaders and managers
Graduate and MBA would be preferred
Microsoft Office, CRM implementation and workflow knowledge
Excel spreadsheet functions and formulas
Contact Centre Quality analysis and call audits
Good knowledge of Call Quality, NPS & C’SAT metrics

Team Leader Quality Resume Examples & Samples

Monitors and verifies the HACCP plan’s CCPs adhering to policy and procedure
Works with operations personnel on quality and safety issues
Verifies operations control systems are functional and being followed
Coordinates resolution of customer complaints as necessary
1-3 years related experience required preferably in the food industry
Ability to read, write and speak fluent English
Ability to prioritize and manage tasks

Team Leader, La Field Quality Resume Examples & Samples

Coordinates quality issues that span multiple business units and multiple districts
Instructs Field Sales & distributors in Quality related procedures and tools
Technical degree
Minimum of 5 years of managerial experience
Project management skills required. Commercial and communication skills required. Product knowledge of RA products is preferred. Experience with handling RA customer issues is preferred. Experience with RA quality systems is preferred

Quality Leader Resume Examples & Samples

Comply with all company and departmental policies and procedures
Meet and/or Transition Quality System requirements as necessary to meet customer satisfaction requirements
Serve as the Philosophical Leader for adherence to Customer requirements, TS requirements, training requirements, RTFT, Audits, Standard Work and documentation
Maintain and build excellent customer Quality Satisfaction
Partner with Customer Quality Engineers assure timely and effective closure of customer complaints
Primary plant contact for all Quality issues associated with Plant Production
Ensure plant customer complaints are immediately contained and corrective actions are implemented and verified
Responsible to represent the “Voice of the Customer” inside production operations to assure alignment between Launch requirements and actions, QMS (Quality Management Systems), Quality Production requirements, Commercial, and customer expectations
Ensure departmental created documentation is organized and readily accessible
Maintain systems consistent TS 16949
Provide support as required for the various value stream activities with to effectively implement procedures and systems and ensure conformance to system and customer requirements
Participate in discussions with Organizational and Plant management including presentations of strategies, goals, activities, in all areas of responsibility
Appraise the performance of associates. Formulate training plans for continued improvement of associates’ skills to meet changing organizational needs
Prepare annual department capital, expense and manpower budgets
Ensure budget compliance throughout area of supervision
Maintain Key Performance Indicators (KPI’s) for internal and external quality performance and manage associated corrective action activities as required
Serve as an active member of the Plant staff to help guide the intermediate and long term improvement of processes relative to KPIs and Development of people
Drive continuous improvement in all areas of responsibility

Opsdata Quality Team Leader Resume Examples & Samples

Responsible for providing core IT Operational support to key functional areas in Santander Operations
The department aims to ensure high-level of accuracy in data quality by taking direct ownership of data in the Core IT System
The departments are also responsible for establishment of daily operational control processes by tracking, testing,analyzing and reporting of key conditions
To meet this objective, metrics are run on the databases and analysis isdone of data that flows from one database to another to validated and ensure consistency in data
Action plans are designed to correct errors that are discovered during such analysis
Assesses the relative priority of the request against others from same or other business teams
Provide management oversight of new product initiatives to ensure appropriate delivery to the business
Gather information and review processes. Implement new procedures, metrics and targets
Manage planning, operation and problem solving so that team meets its goals and SLA
Ensure team stays on schedule and meets their daily requirements or performance metrics
Work closely with other team members to resolve issues/ incidences and report as required on performance, issues and resolutions
Responsible to disseminate information to team and forward information to line up
2+ years exp in accounting, auditing, IT, finance
At least 2 years
Advanced knowledge of SQL and Access. Strong experience in Excel, Power Point, creating and designing reports is required.,
Demonstrable time and team management skills, with the ability to work effectively in a cross-functional environment
Should be detail oriented
Have the ability to adapt to a constantly changing environment and work independently

Team Leader Quality Test Laboratory Resume Examples & Samples

Planning and coordination of all activities in the test laboratory
Technical and disciplinary management of 8 employees
Targeted employee development
Organize and monitor all laboratory procedures regarding maintenance, work safety and compliance with environmental requirements
Establishment of necessary tests on products, preparation of test plans
Conception of product-specific test equipment for all test tasks in the test laboratory
Initiate and carry out tests in the laboratory, compilation of test reports
Conducting analyzes, reporting on products and components, preparing 8D reports
Technical contact accross our sites as well as for customers in connection with validation tests and complaints
Collaboration in project teams and FMEAs
Participation in internal and external audits

Team Leader PD Quality Services Resume Examples & Samples

Provide leadership and line management to the team across multiple locations
Ensure that the performance of employees is proactively managed and they are coached, trained and developed in order to maximize their contribution
Ensure that staff communication and employee relations are managed proactively to maximize the wellbeing of the employees
Actively install the Roche values in the team and their activities
Identify future resource needs and identify, recruit, train and develop appropriate talent
Establishes, maintains and fosters strong relationships with key business stakeholders and ensures that PDQ is providing efficient, effective, value added controlled documents to the functions
Proactively identifies needs and areas for improvement. Ensures that business partner expectations for the controlled document and training strategy, associated documentation and deployment are met. Ensures first Level support issues (e.g. user requests, change control, etc.) are resolved in a timely manner
Proactively identifies and follows up training non compliance through robust compliance metrics and reports
Partners to support corrective and preventive actions (CAPAs) resolution for inspection and audit findings
Contributes to the PDQS Leadership Team to set strategies and achieve the long-term goals & objectives for PDQ QS and PDQ as a whole
Is knowledgeable of all services and activities provided by PDQS in order to provide business stakeholders with a comprehensive overview and effectively communicates how their needs can be met
Independent development of GxP Standards; Policies & SOP throughout all of the Roche development related organizational enterprises (gRED, pRED, PD, GPS and affiliates) to ensure a consistent documents landscape for standards and processes related to clinical development and safety/pharmacovigilance which meet internal and external standards versus regulatory and compliance related regulations and interpretations
Ensures via the Standards & Governance team in collaboration with business partners that Policies and SOPs in the controlled document landscape are up-to-date and regulatory compliant versus current Clinical and safety/pharmacovigilance international regulations
In close collaboration with supported functional areas and key business stakeholders, proactively identifies needs for process standardization, regulatory compliance direction and areas for improvement

Leader, Field Base Quality Resume Examples & Samples

Assists field sales in the resolution of commercial issues resulting from product anomalies
Escalates problems with products or customer service processes to the Quality organization and respective business units. Helps to drive toward solution by making sure sufficient information has been provided to RA, the right people are involved within the Quality organization and business units, and appropriate urgency exists
Responsible for communication to district sales on top issues, status updates, and resolution of issues
At least 5 years of experience in developing corrective action plans and driving issues to resolution
Project management skills required
Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas for this job opening
Any offer of employment is conditional upon the successful completion of a background investigation and drug screen
Experience with handling RA customer issues is preferred
Experience with RA quality systems is preferred

Senior Global Leader of Quality Resume Examples & Samples

Be passionate about providing leadership in support of the production of state-of-the art implantable medical devices
Have extensive experience with Quality, Regulatory, and Clinical activities
Be energized by working for a world-class manufacturer and collaborating on cross-functional teams
Recognize the importance of building and maintaining strong interpersonal relationships
Providing organizational leadership for Regulatory Affairs, Quality Assurance, Clinical Affairs, Medical Affairs, and Medical Contracts functions
Ensuring the functions are performing effectively to satisfy business goals and to mitigate compliance risk
Ensuring optimal integration of medical-specific functional efforts
Ensuring GORE Medical maintains excellent relationships with regulatory agency personnel and related industry stakeholders globally
Coaching and mentoring the global functional leaders; confirming functional goals and strategies are aligned with and meeting divisional and enterprise needs
Working collaboratively across functions and teams to support development and commercialization plans and lifecycle management strategies
Advocating for the global functional leadership team with internal stakeholders; helping to shape divisional strategy
Holding functional leaders accountable for development and execution of
B.A. or B.S. undergraduate degree
At least 15 years of quality, regulatory, and/or clinical experience in a medical device, pharmaceutical, or life sciences technology driven company
At least 5 years of experience in strategic planning and collaboration with executive and key operational groups
At least 5 years of progressive leadership experience as a “leader of leaders”; providing direction and support for quality, regulatory, and/or clinical organizations with global responsibility and establishing long-term strategic growth initiatives
Experience with or knowledge of the product development lifecycle, including concept, design, implementation, verification and validation activities necessary for product commercialization
Extensive experience with cGMP, GCPs, ISO 13485 and other Regulatory compliance requirements
Experience with regulatory filings for US (510(k), IDE and PMA), Europe and Japan
Experience interacting with and influencing external regulatory agencies and trade associations (such as AdvaMed, Eucamed, ISO, MDIC or similar) and physician key opinion leaders and regulators
High level of personal and professional integrity, trustworthiness with strong work ethic, and the ability to work independently with minimal direction
Excellent communication and presentation skills
Ability to develop and manage a high performance team focused on accountability and meeting and exceeding expectations
Ability to lead, influence, create and work within cross-functional and cross-regional team environments
Strong results orientation, positive “can do” attitude and a sense of urgency to get things done
Advanced degree
Experience with ISO14155, 21CFR Part 4
Experience with combination products (drug-device)

Leader, Field Based Quality Resume Examples & Samples

Prioritize and maintain a real time listing with updated status of customer quality issues within the District for focus, territory, global, and vertical accounts
Visit customers throughout the year and provide trip reports on actions or VOC
Follow up with customers or sales engineers on all issues to verify closure. Follow up on “unresolved” Quality complaints from the customer experience survey
Performance of these duties requires a substantial amount of teaming with all Rockwell Automation Field Sales and Business Support Functions at various levels within the company
Bachelor’s degree in an Engineering or Business discipline, or equivalent degree or education
Product knowledge of Rockwell products is preferred
Experience with handling Rockwell customer issues is preferred
Experience with Rockwell quality systems is preferred

Shift Quality Leader Resume Examples & Samples

Monitor all quality parameters
Understand causes for quality defects
Make necessary adjustments to bring tow within specification
Investigate and document non-conformance through corrective/ preventative actions and customer feedback
Assist in developing documentation of work instructions, processes
Coach employees on our current quality systems and new processes as they develop
Perform in-process inspection and audits/ 10% overtime is required
Work rotating shifts
Demonstrate excellent verbal and written communication skills
Dexterity with simple hand tools
Ability to multi-task and adjust to work demands and designated by management
Extreme attention to detail
Exceptional organization skills
Intermediate capabilities with Microsoft Word, Excel and Access
Experience navigating in SCADA (supervisory control and data acquisition) and PI Process Book
Ability to mine data for quality analysis
Ability to utilize statistical process control tools
Knowledge of Extrusion SOPs (Standard Operating Procedures)
Knowledge of Tow manufacturing
Experience with the implementation of proactive quality strategies

Source Approval Integrated Quality Team Leader Resume Examples & Samples

Lead and collaborate OEM and Aftermarket managers in ensuring product and process compliance by providing guidance and direction with regards to quality systems and requirements
Lead executive level Quality initiatives the include the Quality, Operations, and Engineering Teams, Third party providers and regulatory agencies to execute the continued improvement plans and meet customer requirements
Provide leadership to solve quality challenges to ensure success and customer satisfaction
Attract, develop and mentor diverse talent in ESA/MCL
Foster and maintain a cooperative relationship with our key regulatory customers. (FAA & DCMA)
Drive product and process improvements that ensure customer’s quality metric goals are met (Escapes, Scrap, Rework and Process Cert)
Drive a culture of continuous improvement through the use of ACE tools to implement change, eliminate escapes and reduce cost and lead times
7+ years Aerospace Manufacturing, Quality or Engineering
Bachelors Degree in Science, Engineering or other related technical field
An understanding of P&W Quality Procedures, Engineering Source Approval or aerospace material processing
Demonstrated leadership of multi-discipline teams
Demonstrated ability to interface with all levels of management and external customers (DCMA, FAA)
Ability to lead projects, develop and mentor other leaders
Strong interpersonal and communication skills and ability to facilitate and motivate teams
Knowledge and experience with root cause and process control tools
Experience in using ACE tools to make process improvements
Experience with SAP and Microsoft suite desired