Staff Quality Engineer Job Description
Staff quality engineer
provides leadership, technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems.
Staff Quality Engineer Duties & Responsibilities
To write an effective staff quality engineer job description, begin by listing detailed duties, responsibilities and expectations. We have included staff quality engineer job description templates that you can modify and use.
Sample responsibilities for this position include:
Ensure compliance to the laid down quality system requirements and ISO 13485 standards
Lead or support teams to investigate supplier and external manufacturing quality issues (Failure investigations) to resolve complaints, non-conforming products and CAPA
Lead the preparation of validation and qualification protocols and support the execution of supplier and external manufacturing process /product qualifications & validations (IQ, OQ, PQ) projects
Management of Supplier Change Notifications with suppliers and external manufacturers
Participate and collaborate with Supply chain, R&D Engineering, Operations Engineering and Manufacturing to identify potential areas of process variability, address root causes and implement improvements
Participate in preparation of Process/Design Failure Mode and Effects Analysis (PFMEA / DFMEA)
Update plant staff on supplier quality metrics and performance at the Management Review of the Quality System and the Management Review Board
Perform other work-related duties as assigned by the manager of the role
The Staff Quality Engineer supports the Pharma organization in gathering complaint data and interpretation of complaint data, early detection and trend detection
Ensures appropriate metrics/ Key Performance Indicators are defined, measured and analyzed to ensure process compliance and continuous improvement opportunities and follow up of product performance
Staff Quality Engineer Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Staff Quality Engineer
List any licenses or certifications required by the position: ASQ, CQE, ISO, CMMI, CQA, AS9100, 9001, III, CQT, ESD
Education for Staff Quality Engineer
Typically a job would require a certain level of education.
Employers hiring for the staff quality engineer job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Science, Technical, Computer Science, Math, Technology, Education, Electrical Engineering, Chemistry, Life Science
Skills for Staff Quality Engineer
Desired skills for staff quality engineer include:
Applicable regulatory
ISO 13485
Unit requirements
Design control principles
Six sigma methodology
Medical Device
FDA requirements for design control of medical devices
Others relevant to Medical Devices
Good Manufacturing Practices and ISO policy and procedures
Desired experience for staff quality engineer includes:
A Master’s degree and 4 years’ experience in Software Development is required
Must have worked on projects using the AGILE Software Development
A minimum of a Bachelor’s Degree in Chemistry or Chemical Engineering, is strongly preferred
FDA and ISO regulations knowledge is required
Experience with CNC Milling and Turning
This position requires a minimum of a Bachelor of Science degree in Electrical Engineering (BSEE) or Mechanical Engineering (BSME) or Chemical Engineering (BSCE), or a related technical field
Staff Quality Engineer Examples
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Staff Quality Engineer Job Description
Job Description Example
Our company is growing rapidly and is looking for a staff quality engineer. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for staff quality engineer
- Ensure effective risk management to prevent unanticipated failure modes and ensure capability using risk assessment tools / methods (dFMEA, pFMEA, Why Why analysis )
- Prepare and rigorously monitor Product Quality Plan for New Products
- Develop packaging for new products and improve existing packaging to enhance market acceptability
- Provide technical support and information to QA, Production, SQM, Sourcing
- Perform a variety of routine and non-routine tasks in compliance with current good management procedures based on a strong knowledge of stability procedures and systems
- Design and develop New and Modified products / Packaging as per customer requirements
- Support Operations, Engineering in executing process specifications, process validations, process control and process risk management
- Support Operations, QA in the investigation / correction of process failures
- Implement and monitor process capability for continuous improvement using SPC (Statistical Process Control) techniques
- Analyze study results, and independently makes tactical decisions
Qualifications for staff quality engineer
- Demonstrated application of statistical methods
- Thorough knowledge of quality system regulations/requirements
- Demonstrated ability to perform multiple tasks and ability to effectively manage conflict
- Proven ability to work in teams to obtain results, self motivated/directed, ability to organize and supervise people and activities, minimal supervision required
- Understanding of GD&T (Geometric Dimensioning and Tolerancing) is preferred
- Bachelor’s Degree in engineering, related science field, or equivalent
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Staff Quality Engineer Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of staff quality engineer. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for staff quality engineer
- Solve complex problems by applying both their engineering knowledge, and using standard problem solving methods such as DMAIC, 8D, DFSS to diagnose, solve and prevent product design and manufacturing process issues, ensuring incoming and outgoing quality requirements are met
- Work in a self -motivated/directed manner, organize projects, tasks, activities with minimal supervision
- Provide technical expertise and engineering excellence support
- Serve as a multi-functional quality team member providing guidance for life cycle engineering, product development, and continuous improvement projects, assuring commitments and objectives are achieved with positive results
- Own and drive Situational Analyses , review quality documents such as NCMRs, CAPAs, validation protocols (IQ/OQ/PQ), FAT/SATs (Factory/Site Acceptance Testing) and change control, for effectiveness and compliance to Corporate and Unit Quality guidelines, with timely execution
- Work closely with the Sumter SC plant Leadership Team to achieve plant quality and business objectives
- Is a core team member for complex design control / process control projects
- Support and can lead quality system audits
- Provide input to management review process
- Lead quality improvement actions together with customer, plants and product lines in serial life
Qualifications for staff quality engineer
- Demonstrated ability to conduct internal / external Quality Systems audit
- Bachelor’s degree in a technical discipline, preferably Computer Sciences, Information Technology, or other Software Engineering related discipline
- Strong knowledge of Software Development Lifecycle Processes
- Understanding of 21 CFR820 and IEC-62304
- Professional certifications (CQE, CQA) are desirable
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability
3
Staff Quality Engineer Job Description
Job Description Example
Our growing company is looking for a staff quality engineer. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for staff quality engineer
- Demonstrates strong proficiency in applying established tools and methods (for example, Six Sigma, Lean, Kaizen, ) to identify and realize new product or process introductions, process and business improvements
- Participates on Six Sigma improvement projects, including coaching and development of employees
- Serves as technical review for validation activities, protocols and reports
- Develop personal performance objectives based upon the facility quality objectives, reporting monthly on progress made against those goals
- Providing Quality System Regulatory interpretation, consulting, training, and assessment to ensure product teams are aligned with current regulatory requirements, standards, and current industry trends
- Lead complex investigations, coordinate technical teams to ensure sound experimental design, effective data analysis, risk analysis, design verification and validation and subsequent closure to technical investigations
- Provide constructive technical challenge to the design and development of a product or process to drive better product or process performance and project outcomes
- Provides guidance on data analysis and statistical tools to conduct or support of trend analysis, root cause analysis, failure investigation, and risk assessment
- Ensure the Safety and Reliability requirements for the products and provides leadership in driving to full implementation of requirements
- Initiate and supports continuous process improvements within area of responsibility, and conducts supplier quality system and product audits as needed
Qualifications for staff quality engineer
- Exhibiting professional behavior with internal and external business associates
- 4 to 7 years Software Quality / Software Development / Software Testing
- Track record of implementing and improving product software related processes
- Skilled to lead, mentor and train teams on relevant processes
- Experience with regulated environments for in vitro diagnostics/medical devices
- Experience with and knowledge of applicable regulations and standards
4
Staff Quality Engineer Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of staff quality engineer. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for staff quality engineer
- Test method validations
- Advise on Regulations
- Provide functional support to cross-functional teams
- Usability Engineering/Human factors
- Perform Supplier qualification, routine, and “for cause” quality audits as needed by target timelines to assess the compliance to applicable regulations, standards and requirements
- Administer the supplier change notification system
- Perform Quality Supplier Management activities including participation in the monitoring of supplier performance and provide nonconformance supplier quality metric inputs to the Supplier Steering Committee
- Perform and/or support continuous improvement projects
- Provide all planning necessary to ensure product acceptance
- This position will serve as a functional representative for organizational initiatives potentially impacting or affecting the QMS
Qualifications for staff quality engineer
- Responsible for escalating potential risks to management
- Responsible for exhibiting professional behavior with both internal/external business associates that reflect positively on the company and is consistent with the company’s policies and practices
- Other such duties as may be determined by Management
- Training in design of experiments and statistics
- Bachelor of Science, Engineering or related subject with 4 or more years of experience in a quality discipline, or
- Must be willing to work as part of a multi-site team, with some travel required
5
Staff Quality Engineer Job Description
Job Description Example
Our growing company is looking to fill the role of staff quality engineer. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for staff quality engineer
- Technical site support and training as required for specific projects, needs, or issues
- Manage quality excursions and drive for effective root cause solutions and preventive actions
- Support Subcontractor process/material change process and site certification activities
- Maintenance of Regional Supplier Audit program
- Provide leadership in the assessment of new subcontractors for a variety of markets (Automotive, High Reliability, Industrial, and Commercial)
- Effectively drive Test subcontractors to address quality issues in a timely manner
- Utilize statistical data analysis to identify key issues in process and recommend actions for improvement
- Identify trends, manage projects & influence teams to drive continuous improvement at regional subcontractor locations
- Perform Supplier Quality assistance in the creation, establishment and installation of best known practices
- Supports and can lead quality system audits
Qualifications for staff quality engineer
- Demonstrated proficiency with statistical techniques such as Six Sigma and Statistical Process Control
- Technical proficiency / experience in multiple quality system areas, including Nonconformances, CAPA, Change Control, Production & Process Control, FDA / ISO Audits, Complaint Management, Risk Management, Design Controls, and/or Validations
- Intermediate to advanced experience with presentation tools
- Experience with statistical analysis packages, JMP, minitab
- 8 plus years industry experience in a quality ore engineering role
- Understanding of discrete or continuous manufacturing methods/processes such as