Freelance Design Quality Engineer (ZZP)

In this role, you have the opportunity to represent Design Quality during the execution of new development programs and sustaining activities and interfacing with regulatory affairs.

You are responsible for:

• Representing Design Quality during the execution of new development programs and sustaining activities and interfacing with regulatory affairs

• Independent oversight of product performance as this relates to Product Quality, Safety and Reliability

• During (early) Development and Lifecycle Maintenance: Participate in establishing the quality and reliability strategy specific to the product(s) in scope. Involved in quality target setting in Project Charter

• Act as a product quality lead by defining the activities in the Product Quality Plan to meet product quality targets

• Contribute to the execution and delivery of results specific to product quality: Review reliability plans , review key quality related requirements , ensure a proper transfer of design specifications to manufacturing and supply chain and service, perform assessment on the design/architecture on suitability for the quality criteria, and review key product related deliverables (Reliability Reports, Reliability modelling for predictive analysis, FMEA's, Change Point Analysis, etc.)

• Apply and facilitate Design for Quality & Reliability best practices (FMEAs, robust design, V&V, root cause analysis & problem solving)

• Regularly go through the history of quality issues (leverage data of post-market analysis like Complaints, Quality Notifications, DeFOA, Defect) and drive improvement through proposals

• Support and lead quality related problem solving and root cause analysis as they relate to design and development and define and establish best practices

To succeed in this role, you should have the following skills and experience:

• Bachelor's degree with 12+ years of related experience or Master's degree with 3+ years of related experience

• Experience in highly regulated and complex industry

• Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards (21 CFR Parts 820, ISO13485, ISO14971, MEDDEV, EU MDR, etc.)

• Experience or understanding of quality tools, methods and standards (Weibull++, Minitab, reliability modeling, statistical analysis, warranty analysis, HALT, ALT, IEEE1624)

• Experience or understanding of Software or Hardware development, Verification and Validation, Risk management, RCA, Requirements Management, Design, Usability.

• Experience or qualification: Design for Six Sigma and Statistics or proven experience in problem solving and root cause analysis tools, Design for Reliability, FMEA, Usability, APQP, Design Form Manufacturing and Test, Meddev awareness, AAMI Design Controls / Risk Management, Program management

• Demonstrated success in leading change for product quality and reliability

• Ability to support development, manufacturing, field data analysis and develop intelligence in estimating current performance and future trends