Design Quality Engineer

Design Quality Engineer

Respironics Inc
5-8 years
Not Specified

Job Description


Job Title
Design Quality EngineerJob Description
In this role, you have the opportunity to support 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 main focus is to ensure End of Life and Lifecycle maintenance activities are timely supported to address amongst others customer complaints, Regulatory Changes, Supplier Change requests .
You are responsible for
  • 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 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)
  • 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 are a part of
The Q&R; organization of MR / IC and DXR 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.
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.
To succeed in this role, you should have the following skills and experience
  • Bachelor's degree with up to 5 years of related experience or Master's degree with 3+ years of related experience
  • 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.)
  • 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

In return, we offer you
  • A rewarding career in Philips with attractive package. `
  • Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
  • Attractive collective health insurance package
  • Opportunity to buy Philips shares and products with discount

Why should you join Philips
Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 2.5 billion lives a year by delivering innovative solutions across the . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by .
To find out more about what it's like working for Philips at a personal level, visit the on our career website, where you can read stories from our . Once there,you can also learn about our , or find answers to some of the .
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Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven. Little did they realize that it would become a global force of innovation, committed to improving billions of lives worldwide. But it did. Today, Philips is a world leading health technology company with a vision to make life better for people worldwide through meaningful innovation. Making good on this promise depends on our passionate, inspirational, collaborative and diverse team. We have over 80,000+ brilliant people around the world but are always looking for more. Like-minded, motivated, focused minds to join us in creating a healthier, more connected society while tranforming themselves personally and professionally. Working at Philips is more than a job. It's an experience filled with unexpected moments that will transform you in lasting and positive ways. Help us improve the world for the better while building a career that no one could have planned for. Even you.

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