Product Quality Engineer
4 weken geleden
In this role as Product Quality Engineer you will lead the Quality, Reliability and Safety of Medical Devices. You will contribute to achieve quality objectives as they relate to: Customer Experience, Complaint Rate, and First Past Yield. You will work in an independent Quality & Regulatory organization with key stakeholders during various stages of the design, development and maintenance of the medical device.
Your role:
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, FMEAâs, Change Point Analysis, etc.)
Apply and facilitate data driven 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
You will be part of the Patient Safety & Quality organization, supporting the Business Unit Magnetic Resonance Imaging (MRI) within Philips Healthcare. We are passionate about serving our customers and making a meaningful contribution to (product) quality. You will work in cross-functional project (core) teams consisting of, amongst others, R&D, Service, and Industrialization. In addition, you will have the ability to interact across different sites as a benefit of being part of a global organization.
You're the right fit if:
Bachelorâs degree with 5+ years of related experience or Masterâs degree with 3+ years of related experience in a 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, Data mining, Verification and Validation, Artificial Intelligence, 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
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
⢠Learn more about our business.
⢠Discover our rich and exciting history.
⢠Learn more about our purpose.
If youâre interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
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