Philips Design Quality Engineer / PQE 

India, Maharashtra 

740139452

Design Quality Engineer / PQE
Job Description

You are a part ofthe Q&R organization of MR and provide support to the Business Unit Magnetic Resonance Imaging (MRI) within Philips Healthcare. You will be located in Pune, India and work closely with your peers in Best, The Netherlands and United States.

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.

Your role:

• Oversight of product performance as this relates to Product Quality, Safety and Reliability
• End of Life and Lifecycle Maintenance activities: 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 design quality / 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 data driven Design for Quality & Reliability best practices (FMEAs, robust design, V&V, root cause analysis & problem solving)
• CAPA and Risk Management activities including leading and participating in teams as well as ownership of such activities.
• 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're the right fit if you have:

• Bachelor’s degree with up to 5 years of related experience or Master’s degree with 3+ years of related experience in highly regulated and complex industry (Medical, Aviation, Automotive etc)
• Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards (21 CFR Parts 820, ISO13485, ISO14971, MEDDEV, EU MDR, etc.)
• Preferred 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 supporting change for product quality and reliability
• Ability to support development, manufacturing, field data analysis and develop intelligence in estimating current performance and future trends

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.
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