Risk Management Quality Engineer

Philips Electronics North America Corporation
Cambridge, MA
23 Oct 2024

Vacancy expired!

Job Title Risk Management Quality Engineer

Job Description If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.

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
  • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
  • BS in Engineering or a related field. MS preferred.
  • 4+ years Quality Assurance, Design Engineering, Systems Engineering, Post Market Surveillance, or related experience in a highly regulated industry. 2+ years' experience with a MS or higher.
  • 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. Learn more by watching this video.

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.

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person's relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

Equal Employment and Opportunity Employer/Disabled/Veteran

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