Risk Management Quality Engineer
In this role, you have the opportunity to
Be a key developer in expanding our Quality & Regulatory Risk Management team for our Connected Care organization. Create and implement new tools and methods to manage risk, which will contribute to the safety and efficacy of medical products that save lives and improve health.
You are responsible for
Collaborate at a systems level with R&D, Clinical, Data Analysis, and other key functions to develop a quantitative approach to risk management.
- Demonstrate expertise by leading cross-functional teams to identify risks, implement risk control measures, and document a robust and living Risk Management File.
- Facilitate the creation of both top-down and bottom-up risk management tools, assessments, processes, and principles, including FMEAs.
- Conduct analysis of existing similar products from the company and competitor products to provide documented compliance and evidence of State of the Art, as part of periodic risk management file updates.
- Assure products meet regulatory requirements for risk management, including FDA QSR, MDD, EU MDR, CMDR, ISO 13485, ISO 14971, and Philips procedures.
- Ensure the systematic and logical conversion of customer requirements to product specifications and post market surveillance codes.
- Create and continually improve procedures and work instructions to ensure reliable, repeatable results.
- Support ongoing compliance improvement initiatives, including CAPAs across the five business groups in Connected Care.
You are a part of
An organization that believes-what you do every day can contribute to the innovative health technologies and solutions we develop that make a positive impact on billions of people every year. Including you. Because you will find when you work at Philips that your professional and personal lives often intersect in unexpected and fulfilling ways. It is our mission to improve people’s lives through meaningful innovation and we want you to play a central role in this by leading teams, driving projects, thinking strategically and inspiring colleagues from all over the world.
To succeed in this role, you should have the following skills and experience
- Bachelor of Science in Engineering or a related field. Master of Science is preferred.
- 4+ years Quality Assurance, Design Engineering, Systems Engineering, Post Market Surveillance, or related experience in a highly regulated industry.
- Extensive hands on experience with the ISO 14971 standard.
- Knowledge of 21 CR 820, ISO 13485, IEC 60601-1, IEC 62366, and IEC 62304 standards.
- Strong understanding of risk management requirements, tools, methodologies, and processes, including use of a variety of accepted methods.
- Demonstrated expertise in managing complex projects and implementing cultural change.
- Excellent customer service and interpersonal communication skills, including regularly leading presentations in front of peers and leadership.
- Experience working within a Quality Management System.
- Green Belt or Black Belt certification preferred.
- Excellent team work skills including influencing and building rapport with internal customers and stakeholders.
In return, we offer you
The opportunity to be part of an organization that is committed to touching 3 billion lives worldwide. The opportunity to use your data analytic skills to support products that provide lifesaving diagnostics and therapy. A chance to grow your professional skills in an environment that values diverse ideas and creative approaches
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 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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