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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