Supplier Quality Management Resume Samples

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J Kassulke

Jaylin

Kassulke

84065 Kerluke Stravenue

New York

+1 (555) 474 7526

84065 Kerluke Stravenue

New York

Phone

p +1 (555) 474 7526

Experience Experience

San Francisco, CA

Senior Engineer, Supplier Quality Management

San Francisco, CA

Ondricka-Zemlak

San Francisco, CA

Senior Engineer, Supplier Quality Management

Carry out supplier performance management activities in relation with local supplies for the Shanghai Supply Chain site
Lead supplier quality improvement initiatives in both APP platform and suppliers side
Rigorous approach in carrying out specified validation works and reporting
Installation and regular maintenance of validation testing equipment used in Shanghai, carrying out adaptations
Test knowledge about pump/valve/pressure sensor testing is plus
Support to vendor search on components and subassemblies, clarification on specifications and validation testing
Effective team player through mutually supportive professional relationship within team and in interaction with other functions (sourcing, manufacturing)

Philadelphia, PA

Director, Supplier Quality Management

Philadelphia, PA

Emmerich, Willms and Wintheiser

Philadelphia, PA

Director, Supplier Quality Management

Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
Willingness to think outside of the box and adapt best practices to this small, but growing environment
Assure audit schedule and approved supplier list (Oracle Agile and EBS) are maintained
Perform audits of and manage audit closure for suppliers of raw materials, components, contract labs, CMO sites, service providers and warehouses
Improve and execute the supplier QTA process (in collaboration with legal and supply chain) and assure a process to assure key quality expectations are reflected in supplier’s operations and updates for changes are managed
Direct implementation and execution of supplier change management system for raw material/component suppliers, contract labs, CMOs and warehouses
Direct the management and enhancement of supplier qualification and specification development processes that will use risk-based tools for qualification, classification and monitoring

present

Philadelphia, PA

Director Worldwide Supplier Quality Management

Philadelphia, PA

Runolfsson, Schmeler and Runte

present

Philadelphia, PA

Director Worldwide Supplier Quality Management

present

Establish, manage, maintain and continuously improve all Quality activities associated supply and contract services including raw materials, components, packaging materials, manufacturing/packaging locations, manufacturing support services, product distribution providers, licensing partners, testing laboratories, affiliate locations and/or acquisitions
Will also establish a Quality strategy and supplier relationship to ensure compliance for all Global Biologics suppliers (internal and external) and contract manufacturing/packaging and testing support services
Will manage the strategy and relationship to ensure that compliant systems and procedures are in place from development and throughout the commercialization life cycle
Manage this balance to optimize continuous growth at the supplier and contractor locations. Directs and provides GMP assessments for potential new suppliers, contract manufacturers, sub-contractors and licensing and acquisition candidates
Lead the establishment and implementation of key worldwide Standardized Operating Procedures and Practices and ensure cross-functional synergies across all Global Biologic facilities in the area of Supplier Quality Management
Establish, maintain, analyze, report and continuously improve the Supplier Quality Performance Measurement system
Develop and manage SQM budget

Education Education

Bachelor’s Degree in Engineering

Arizona State University

Bachelor’s Degree in Engineering

Skills Skills

Strong organizational skills and detail-oriented
Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following
Be Accountable
Strong work ethic and flexible
Be An Excellent Manager of Self and Others
Strong technical, analytical and problem solving skills
Strong influencing and negotiation skills
Customer service focused, balancing quality and efficiency
Actively builds relationships across functional boundaries at multiple levels internally and externally
Be Results Oriented

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15 Supplier Quality Management resume templates

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Supplier Quality Management Resume Examples & Samples

Stay currents of the industry trend and new development
Study and conduct analysis to identify root cause of under-performing suppliers and the gap of their management system
Train and guide implementation of supplier continuous improvement solutions
Deliver trainings to internal staffs for tool familiarization and application
Provide guidance on implementation of continuous improvement process and support problem solving during the course of implementation
Design and establish key performance indicator to measure and report improvement progress of supplier development
Provide support to key projects on sustainable development of supply chains
Review and enhance internal workflow, procedures and guideline to improve operation efficiency and effectiveness
Engage and collaborate with industry think-tank for methods to continuously support elevation of supply chain bottom lines through operational excellence
Prepare Executive project report and presentations

Senior Engineer, Supplier Quality Management Resume Examples & Samples

Carry out supplier performance management activities in relation with local supplies for the Shanghai Supply Chain site
Participating in relationship with Chinese ODM/OEMs and Chinese component suppliers, and communication therewith according to the needs of new product developments and introductions into China, or for maintaining (optimizing, cost reducing, component double sourcing) current products
Support to vendor search on components and subassemblies, clarification on specifications and validation testing
Carrying out validation of new components and subsystems in Shanghai according to specified validation processes
Installation and regular maintenance of validation testing equipment used in Shanghai, carrying out adaptations
To solve component and sub-assembly quality issue in platforms, drive supplier corrective and preventive action in place
Lead supplier quality improvement initiatives in both APP platform and suppliers side
PCBA main board
Electro-mechanical components such as power supplies, electrovalves
Fluid delivery components (tubes and fittings, pumps, filters, flow meters, pressure or temperature sensors…)
Fluid delivery circuits
Ability to communicate in English and Chinese for technical term

Supplier Quality Management Specialist Resume Examples & Samples

Lead audit teams consisting of quality and technical auditors for supplier site assessments requested by Cross-Functional Work Teams. This includes resource coordination, collection and evaluation of evidence, report writing and compilation, problem investigation, and conflict resolution among other audit-related tasks
Plan, manage, and schedule the overall audit program to ensure that supplier assessments are performed in a consistent, timely, professional and high quality manner and that all documentation such as Assessment Reports and supplier database records meet the needs of Cross-Functional Work Teams and other BP stakeholders
Assist Global SQM team, Shared Services and Refining site stakeholders to develop a non-conformance reporting & collection process to monitor suppliers’ ongoing performance and to capture Cost of Poor Supplier Quality (CoPSQ)
Lead the root cause and corrective action activities for suppliers’ product quality related issues
Work with suppliers to improve their quality systems, processes and performance
Lead the initiative to develop and manage the supplier score cards
Develop supplier relationships based on introducing and embedding a Quality improvement culture
Promotes the achievement of Safe, Reliable and Risk Managed Operations for BP Downstream
Support compliance with BP Code of Conduct; provides D&I leadership; embeds processes that achieve HSSE goals and improve supplier safety and reliability
Strong background in quality management systems (QMS) and processes
Experienced in supplier quality management and supplier development programs
Hands-on manufacturing experience as a supplier’s manufacturing site and QMS assessor / auditor
Minimum of 3 year experience in advanced industries like automotive, pharmaceutical, aerospace, etc
Proficiency in use of quality control tools (FMEAs, Control Plans, Process Flow Diagrams, 8D, 5-Why, Statistical Process Control etc), Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP)
Proficient in supplier assessment report writing
Proficient in MS Word, Excel and PowerPoint
Willing to travel up to 50% of the time globally
Bilingual – Mandarin and English speaking is a MUST
Six Sigma Green or Black Belt
ISO Certified Lead Quality Auditor, Certified Quality Auditor (CQA)
Familiarity with Oil and Gas Industry standards (ISO 29001, ASME, API, Q1 etc) and other internationally recognized Quality Management Systems such as VDA, ISO 9001:2008, TS 16949, ISO13485 etc
Ability to work effectively in a cross functional team

Specialist, Supplier Quality Management Resume Examples & Samples

Perform periodic Supplier written assessments and or on-site audits. Recommends action plans to qualify/disqualify suppliers as necessary
Author and negotiate Quality Agreements with the API Suppliers or contracted Third Parties
Maintain executed Quality Agreements in the Supplier files
Assist with the maintenance of Approved Supplier List and other data bases
Assist with the implementation of electronic audit tracking system (Trackwise) and migration of paper base data into the electronic system
Review and follow up with Supplier Questionnaires sent to potential/current supplier of material and GxP services to assess all aspects of the production or provided services
Interact with various departments and each corporate site to ensure that requirements of the SQM program and business priorities are met
Support activities related to external compliance audits related to Suppliers, report generation and Supplier responses
In conjunction with Purchasing Department/Distributors, interact and follow up with Suppliers to ensure timeliness of implementing corrective and preventive action(s)
Maintain a current working knowledge of government and industry quality assurance, trends, codes and standards
Work with Planning/Operations Management to ensure raw material/component changes are in compliance with FDA and other regulatory agency requirements to meet the SQM Program requirements and business priorities
Assess test attributes and specifications of raw material/component acceptance criteria; identify trends in critical material properties and recommend preventive actions to prevent potential issues with material/supply quality or other problems

Manager, Supplier Quality Management Resume Examples & Samples

6+ years’ experience in QA auditing and supplier management (FDA regulated pharmaceutical, biologics and or medical device industries) with BS degree
Experience in FDA and Third Party inspections is required
2+ years' experience working in a cross functional setting (e.g. production, quality assurance/control, process development, and/or regulatory affairs) is required
BS/BA degree required; science degree highly preferred
High level knowledge of computer systems, applications and databases required with specific SAP, TrackWise, Microsoft Access, and SharePoint preferred
Knowledge of pharmaceutical research and development processes and regulatory environments
Formal audit certification preferred; for example ASA certification
Knowledge of drug life cycle from development to commercialization
Advanced degree is preferred

Supplier Quality Management Engineering Manager Resume Examples & Samples

Develop key suppliers on Schneider Electric’s expectations, systems and performance objectives through continuous improvements & collaboration projects on critical business & quality issues
Drive proactive quality, delivery and productivity improvement with Schneider Electric’s supply base
Achieve Supplier’s Quality Performance with Supplier Leader and animate the Supplier quality performance section at Supplier Business Review
Deploy / set-up at quality requirements at supplier base as per Schneider Supplier Quality Management (SSQM) process (DPME & ESSR measurement, 8D, Part Product Evaluation Plan (PPEP), etc.)
Conduct Supplier Quality audits (SAM) upon request from Commodity, Quality or Engineering
Train, coach suppliers when needed (e.g. 8D, SPC etc.)
Represent ITD OCP Purchasing team in Global Supplier Quality Logistics Development (SQLD) network
Bachelor of Science in Engineering (Chemical, Material Science is preferred)
Experienced or knowledgeable in Lead Acid Battery and Electronics manufacturing processes
Ability to prioritize and execute under challenging time constraints
Ability to get things done through influence, using indirect resources in a matrix organization and breaking resistance to change
Excellent communication skills in a multi-cultural environment
Knowledge of manufacturing processes, FMEA, quality control plans, and problem solving methodologies
5 or more years work experience in manufacturing areas such as: quality, manufacturing, design engineering or supply chain
Experience in conducting Process and System audits
Minimum 5 years in project management required, preferably in an international setting
Availability to travel, position requires 20% travel (domestic and/or international)
Certified ISO Lead Auditor or Trained
Fluent in English, both spoken and written
KQS01 ENCR / INCR / ESSR / ISSR KPI's - External Supplier Service Rate (ESSR) /
Internal Supplier Service Rate (ISSR / Key Performance Indicators
KQS02 SSQM / SAM / SQM / SPM - Schneider Supplier Quality System / Supplier
Appraisal Module / Supply Qualification Module / Supplier Performance Module
KQS03 Supplier Appraisal Module (SAM) Audit
KQS04 Part & Product Evaluation Plan (PPEP) & Part/product Qualification
KQS06 Manufacturing Process Audit
C004 Cross-Cultural
FQ03 Quality Metrics and Assurance
FQ05 Quality Authority
FQ06 Supplier Qualification and Development
FQ09 Quality Transverse Management
FQ11 Lean Six Sigma
KQA04 Quality Control Plan
KQT08 Problem to Prevention (8D)
KQT10 FMEA
FP01 Purchasing Administration & Tools
FP04 Purchasing Supplier Management
FP08 Purchasing Tools / Methods
L03 Influence and Convince
L05 Focus on Customer
L06 Foster Collaboration & Networking

Supplier Quality Management Resume Examples & Samples

Lead supplier development strategy, designing the metrics for the function and supplier performance. Lead supplier quality audits
Revise and where appropriate, implement the quality processes within GBS to ensure that the quality of the company’s products and services meets the needs of our customers and that the quality procedures employed are cost effective and efficient
Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance,
Promoting a quality focused culture within the business
Remove nugatory quality related tasks and improve efficiency of processes required to fulfil customer and accreditation requirements
Implementing and cascading the 7 Principles of Quality
Undertaking all Quality associated activities for the introduction of new vendors and ensuring existing vendors comply with our strict requirements and ensuring flow down of customer and business requirements
Be responsible for ensuring that the requirements of the SQRM are implemented and maintained including maintenance of the Company’s Third Party certifications and facilitate a continuous review to ensure that they remain applicable to the business needs
Advise on the application of Quality Processes and be instrumental in the implementation of corrective action if it is believed that the application of the Quality Processes to be inadequate or inappropriately applied or that Customer Quality Requirements are not being met
Have the responsibility to resolve all matters pertaining to Quality aspects to the satisfaction of the Customer Quality Representatives
Be responsible for the planning and implementation of an Annual Audit Programme and conducting a Management Review of the Quality Management System

Director Worldwide Supplier Quality Management Resume Examples & Samples

Establish, manage, maintain and continuously improve all Quality activities associated supply and contract services including raw materials, components, packaging materials, manufacturing/packaging locations, manufacturing support services, product distribution providers, licensing partners, testing laboratories, affiliate locations and/or acquisitions
Will also establish a Quality strategy and supplier relationship to ensure compliance for all Global Biologics suppliers (internal and external) and contract manufacturing/packaging and testing support services
Will manage the strategy and relationship to ensure that compliant systems and procedures are in place from development and throughout the commercialization life cycle
Administer regulatory requirements and Global Biologics/J&J policy and standards to ensure the proper balance of business and compliance needs
Manage this balance to optimize continuous growth at the supplier and contractor locations. Directs and provides GMP assessments for potential new suppliers, contract manufacturers, sub-contractors and licensing and acquisition candidates
Develops policies and requirements for Supplier Quality Management Systems in order to minimize compliance and product quality risk while increasing business portfolio
Writes, negotiates and ensures execution of Supplier Quality Agreements
Facilitates the resolution of Supplier Quality issues as required
Develop and manage SQM budget
Establish, maintain, analyze, report and continuously improve the Supplier Quality Performance Measurement system
Provide trend analysis for future outsourcing business strategy
Will identify opportunities to continually improve quality, cost and time factors, consistent with the Global Biologics business objectives
Establish and report appropriate Worldwide Supplier Quality business measurements, analyze these measurements and identify the most significant issues and prioritize for action
Lead, sell and implement improvement opportunities and problem solutions
Provide regulatory interpretation, consulting, training and assessment to ensure company Supplier Quality Management systems are aligned with current regulatory requirements, company standards and industry trends
Represent Global Biologics on relevant company, corporate or industry projects team or committees as required in conjunction with Worldwide Quality Management formulate Worldwide Quality strategy and requirements for Global Biologics
Serves as technical expert for all Global Biologic Supplier Quality Management functions
Lead the establishment and implementation of key worldwide Standardized Operating Procedures and Practices and ensure cross-functional synergies across all Global Biologic facilities in the area of Supplier Quality Management
Represent Supplier Quality during Regulatory Inspections
A Master’s Degree in Quality Management, Engineering or related field is required
A minimum of 10 years’ experience in a medical device, pharmaceutical or similar regulated industry is required with a minimum of 3 of those years in a Quality Leadership role
Previous people management experience is required
Experience managing multiple leveled employees in a global capacity is preferred
Must have a demonstrated ability to effectively develop and negotiate Supplier Quality Agreements to ensure compliance with regulatory requirements and business needs
The candidate must have broad based technical knowledge and skills in diverse areas of business such as Quality Engineering, Quality Assurance, Quality Systems, Pre production Quality as well as good working knowledge of related functions such as operations, supplier management and product development
Experience in auditing to both FDA QSR and ISO 9000 standards is required
Previous experience managing multiple projects is a required
Demonstrated knowledge of business impact of compliance issues and risk management is required
Ability to effectively negotiate and influence upper management, other departments and regulatory agencies is required
Expert knowledge of Good Manufacturing Practices, regulations and validation methods is required
Ability to clearly communicate to a variety of audiences, both big picture ideas as well as technical details is required
Experience of developing concise and audience-focused communications, both written and for presentations is required
Excellent communication and interpersonal skills are required
Ability to represent J&J in a leadership capacity at a variety of external forums is required

Supplier Quality Management Engineer Resume Examples & Samples

Effective Interpersonal Skills
Must be adaptable to change and be able to perform in a dynamic environment with constantly changing requirements
Good problem solving and analytical skill

Supplier Quality Management Resume Examples & Samples

Immediate response in Asia (8D verification, process audit, conference call…)
Support touch panel/glass suppliers quality improvement program
Responsible for glass (in the area of LCD panel, touch panel and cluster cover) qualification
Bachelor or Master Degree with 5 year relevant industry (LCD/TP/Glass) experience (minimum)
Familiar with automotive quality requirement (8D ,TS16949: APQP. PPAP. MSA, SPC)
Fluent in English speaking, reading and writing
Have experience about project management
Process audit skill (preferred)

Supplier Quality Management Resume Examples & Samples

Maturity Evaluations, Feasibility Commitment,
Supplier Component Reviews,
APQP Project Reviews,
Run@Rate, Safe Launch Concept,
Quality Control Plan,
VDA 6.3 Lead Auditor status or working towards
PFMEA Process Failure Modes Analysis
IMDS,
GD&T per Continental Automotive Standards

Supplier Quality Management Electronics Engineer Resume Examples & Samples

Support sourcing process to select best-in-class components and suppliers
Perform the electronic component qualification activities based on the APQP process and in compliance with Continental Quality and Reliability standards
Support the consequent supplier management activities to track any quality deviations (zero tolerance for defects) including support of quality incident escalations from our Plant SQM and Business Units
Drive supplier improvement programs
Conduct VDA 6.3 Audits at the supplier
Use and support the data systems to collect and evaluate electronic components data and supplier quality related key performance indicators (KPI's), issue periodical quality performance reports and ensure that appropriate improvement actions are initiated
Support of Change Management (PCN – Product Change Notifications) for assigned categories and suppliers

Purchasing & Supplier Quality Management Controlling Asia Resume Examples & Samples

Strong analytical capability
A team player and can work under pressure
Excellent English both in oral and written

Supplier Quality Management Engineer Resume Examples & Samples

Bachelor’s degree in Engineering or Science required (Mechanical Engineering preferred)
Minimum 3 years of professional experience, ideally in supplier quality management working in automotive industry
Knowledge of principles and procedures of the following automotive quality methods and tools related to quality assurance: Advanced Product Quality Planning (APQP), VDA Audits, Production Part Approval Process (PPAP), Safe Launch Concept, Statistical Process Control (SPC), DVP&R, FMEA and Six Sigma
Problem solving and statistical analysis methods: Is/Is Not, Ishikawa, 5 Whys, DOE, Weibull, 8D
Project, Change and Risk Management skills
Strong interpersonal and leadership skills (team skills, conflict management, open minded, open for contacts)
Product specifics (gasoline fuel system and after treatment products), manufacturing technologies, test strategies, project management
Previous experience and knowledge of mechanical manufacturing techniques and equipment to include metal stamping, casting, welding, brazing, etc
Experience with analysis and development of mechanical components, qualify new suppliers and purchased part approval
Six Sigma, Green Belt certified
German and Spanish language is a plus
Continental Automotive systems for Component Tracking Tool (CTT) and Conti. Library Management System (CLMS)
VDA Lead Auditor Status

Director, Supplier Quality Management Resume Examples & Samples

Provide leadership for the management and improvement to the Supplier Quality Management Program
Accountable for the GMP compliance of the Supplier Quality program elements: audits, QTAs, SCARs, management of supplier initiated changes
Lead, develop and manage the SQM team to assure compliance of the SQM elements. Manage cross-functionally within Kite and with the external suppliers and service providers to assure compliance and strong relationships
Direct the management and enhancement of supplier qualification and specification development processes that will use risk-based tools for qualification, classification and monitoring
Perform audits of and manage audit closure for suppliers of raw materials, components, contract labs, CMO sites, service providers and warehouses
Improve and execute the supplier QTA process (in collaboration with legal and supply chain) and assure a process to assure key quality expectations are reflected in supplier’s operations and updates for changes are managed
Direct implementation and execution of supplier change management system for raw material/component suppliers, contract labs, CMOs and warehouses
Assure audit schedule and approved supplier list (Oracle Agile and EBS) are maintained
Provide direction to team when Quality contact for supplier issues and discrepancies, and lead/manage the investigations to resolve the issues as warranted for significant matters
Support inspection readiness plans and interact with regulatory agencies during inspections on SQM-related matters, as needed
Ability to travel up to 10%

Supplier Quality Management Resume Examples & Samples

Provide inputs to Central SQM
Plan, initiate and control preventive orientated, advanced quality management measures in the design / development phase (supplier APQP) for mechanical parts and services (Feasibility Review, Project Reviews, Run
Coordination within plant for all PCN's / component release and coordination of PCN for defined categories
Support for plant specific improvement activities in root cause analyses / the definition / implementation of appropriate counter measurements at the supplier to ensure that the parts and services meets the defined quality requirements; Initiate, lead and drive plant specific supplier improvement programs
Professional experience (at least 2 years) in aluminum die casting, stamping or machining manufacturing process
Experience in automotive business (approx. 2 years) and understanding of automotive environment
Experience with supplier development and component introduction (APQP & PPAP)
Experience with customer contacts, continuous improvement, quality assurance, Six Sigma, industrial engineering, production, preferred
Experience in working with international teams on quality issues
Cross functional experience, preferred
Good English communication in both written and speaking

Corporate Lead Supplier Quality Management Resume Examples & Samples

Academic degree/working level
Independent self starter
Communication in different cultural settings
Proactive, dynamic, drive, sense of urgency

Supplier Quality Management Specialist Resume Examples & Samples

Ensure adherence to domestic and international regulations and company policies/standards
Partner routinely with site stakeholders and management to understand priorities, align on expectations and escalate issues in a timely manner
Support regulatory inspections and related activities
Lead continuous improvement efforts to ensure efficient and compliant SQM program
Support an environment of teamwork and collaboration
Previous Biologics, Pharmaceutical, Medical Device, or Plasma Quality Operations experience
Previous Supplier Quality Management, Receiving and Inspection, and/or Audit experience

Quality & Compliance Leader Supplier Quality Management Resume Examples & Samples

Scientific Master degree (Pharmacy, Chemistry, Engineering or related field)
8 to 10 years of pharmaceutical drug product industry (or related industry) experience
A broad and deep working knowledge of the pharmaceutical drug product (preferred) or Cosmectics, operating functions of quality and compliance, material supply, material handling and control, product manufacturing, and product packaging gained through

Technical Expert Assigned to Supplier Quality Management MGM for Plastic and Resume Examples & Samples

Do the technical evaluation for the potential new suppliers regarding process, production and quality capabilities for new or transfer series projects
Support the technical discussion with supplier and development team for new projects in the acquisition phase
Lead development programs with Hella strategic suppliers

Supplier Quality Management Professional Resume Examples & Samples

Bachelor’s degree in a scientific discipline, with five to seven years experience in the pharmaceutical industry, with a background in Quality Assurance, Regulatory, or Procurement preferred
Ability to understand and interpret and apply government and industry standards and familiarity with industry regulatory and inspection requirements
Excellent oral and written communication, interpersonal skills, and computer literacy
Ability to work independently against multiple deadlines
Auditing experience or certification in the pharmaceutical industry desirable
Available to travel a significant portion of the time, often with short notice
Strong analytical skills, with training in continuous improvement and SAP preferred

Supplier Quality Management Resume Examples & Samples

Immediate response in Asia (8D verification, process audit…)
Support Q.BIC program from Asia (supplier process improvement)
Responsible for LCD component qualification in region
Bachelor or Master Degree with 5 year LCD industry experience (minimum)

Mgr Supplier Quality Management Resume Examples & Samples

Support Global Product Quality lead to ensure that all required internal and external audits are planned and scheduled
Leads and conducts audits of contractors and suppliers to ensure compliance with Global and Local Otsuka, and applicable regulatory requirements
Ensure that audit documentation is accurate, complete, and issued within the required timeframe
Review and approve CAPA plans for audit observations
Interfaces with Contractors, Suppliers, Tech Operations, Technical Services and Supply Chain, and Clinical Supply Operations to drive Quality improvements that minimize the Costs of Quality, specifically for component, materials or finished product suppliers
Compiles and reports key performance indicators, metrics and compliance status of Internal Audits and GMP Outsourced Activities to Senior Management
Provides reports and trends to the Otsuka Management Representative to help in the preparation of Management Reviews and/or other ad hoc reporting requests
Author Standard Operating Procedures, work instructions, forms, templates and other documents associated with the audit process as needed and for periodic review
Works collaboratively within Global Product Quality and other functions across Otsuka Affiliates and Subsidiaries to ensure compliance to internal standards and regulatory requirements
Assists in the development of training programs for inspection readiness and improvements with Internal Audit and Supplier Quality Programs along with other Quality Systems
Participates in Inspection Readiness activities and supports Regulatory Inspections
Interface and support project teams to ensure that the goals set by the team as they relate to potential contractors/ suppliers are consistent with global and local quality objectives and relevant governmental requirements
Bachelor’s degree in Biology, Chemistry, Engineering or other Physical Sciences 2- 5 years of experience in pharmaceutical manufacturing and/or medical device, QA or QC roles
1 or more years of Supplier Quality and Internal Auditing experience in the pharmaceutical or medical device industry
Working knowledge of FDA 21 CFR Parts 820, 211 and 210 quality system requirements
Ability to handle contractor/supplier audit situations and interactions in a tactful, professional and effective manner
Ability to manage and prioritize multiple tasks
Ease with electronic environment/ computer skills and Innovation skills

Senior Supplier Quality Management Specialist Resume Examples & Samples

Provide supplier development and support suppliers for production material, pass-through parts and external processing services for preseries
Give initial preseries sample approval of suppliers in the plant
Support in quality and delivery problems
Manage procurement projects in the plant
Coordinate interfaces, deadlines & dates with suppliers as well as services of suppliers
Test suppliers risk, availability, reliability and security
Conduct negotiations
Examine intermediate results on the basis of milestones during the project and, if necessary, clarification of corrective actions with customers, suppliers and internal departments
Coordinate procurement projects
Carry out incoming goods inspection in the plant
Handle supplier complaints in the plant

Manager Supplier Quality Management Resume Examples & Samples

High level professional with background in Infant food QA management, in medium/large international organization
Affinity with procurement processes
Food & FMCG
People management: managing, motivating
Relationship building (also across departmental boundaries and between various management levels)
Languages: English, preferably also Dutch

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