You Role:
- While positioned within the Business Unit MR, reporting to the Segment OEM & Coils DQE Leader, you will support the Quality, Reliability and Safety of Medical Devices though all lifecycle phases of the medical device.
- 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.
- Representing Design Quality during the execution of current 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 t
📌 Design Quality Engineer (Pune)
🏢 Philips
📍 Pune
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