Product Quality Assurance Engineer
Job DescriptionIn this role, you have the opportunity to
Be the spider in the web of product quality. Be part of multi-disciplinary project teams and assure integral quality across the entire product development life cycle of medical products. This involves being a confident advisor on customer-, manufacturing and compliance related topics; all to assure a timely release of innovative products that deliver high quality and outstanding reliability to the lives they will improve. After COVID you have to be about 2 to 3 days a week in the office in Best.You are responsible for
You are a part of
- Ensuring that appropriate quality plans are made that include all stages of life cycle of the product and supports Quality Plan design.
- Validating key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.
- Providing effective oversight of the execution of the Quality Plan, any Risk Management process activities, and of all design related activities during the product/system lifecycle
- Working with product engineering to develop reliability requirements and decompositions, establish a reliability program and perform appropriate analyses to ensure that new medical products meet all appropriate requirements.
- Key contributor in the product development process to ensure the reliability of the product is statistically validated, supporting new product launches and existing product support.
- Performing independent technical assessment on product quality performance and post-market product quality analysis
- Leading quality related problem solving and root cause analysis during design and manufacturing to ensure that Product / System design meets quality and compliance standards for every milestone
- Post product launch monitor field performance and if problems arise, work on failure root cause analysis, corrective action development and resolution verification.
- Act as a single point of contact (person assigned to project team) responsible to ensure that
IGT System Q&R team. This team consists of various functions Quality and Regulatory and you will work closely with these functions based on specific projects. You work in a fast growing and innovative Design Quality Assurance/Quality Engineering team, within an ever-changing environment - constantly striving for improvements and exceeding internal and external stakeholder expectations. The team consists of about 8 team members in Best and 4 in India.To succeed in this role, you should have the following skills and experience
In return, we offer you
- Bachelor/Master’s degree in Reliability Engineering, Mechanical, Electrical or Software Engineering
- At least 4 years’ Design Quality Assurance/Quality Engineering (product quality, reliability engineering) experience in Medical Devices or Pharma is required.
- Understanding of global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, MDD/MDR and ISO 14971 (required)
- Knowledge of Risk Management / DFMEA (Design Failure Mode Effect Analysis) is required
- Some knowledge of APQP / Design Transfer / Design for Manufacturing (DfM) / Lean Methodologies / 5-Why / Problem Solving techniques
- Experience in reliability modeling, statistical analysis, warranty analysis, HALT, ALT, transfer functions, dFMEA, and fault tree analysis.
- Possess a high-level of self-motivation and ability to work in a team. Ability to effectively manage time, organize and prioritize work, multi-task across many assignments is necessary. Effective interpersonal, written and oral communication skills expected.
We welcome you to a challenging, innovative environment with great opportunities for you to explore. Our benefits are very competitive and designed around your preferences:
Why should you join Philips?
- A market conform salary
- 25 Days of leave and the possibility to purchase up to 20 extra days off annually
- A variable bonus based on both Philips results and personal performance
- Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
- Solid company pension scheme and attractive collective health insurance package
- Opportunity to buy Philips shares and products with discount
- Healthy work-life balance
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
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