Sustaining Quality Engineer

Job Title

Sustaining Quality Engineer

Job Description

In this role, you have the opportunity to
Be a key developer in our Quality and Regulatory team for our IGTD organization. Support sustaining products, analyze complaint data and provide feedback to development and manufacturing teams on potential product improvements, product defects and safety evaluations.

You are responsible for

  • Collaborate at a systems level with Quality, R&D, Clinical and other key functions to support sustaining products design changes.
  • Analyze complaint data, gather additional data as needed, and partner cross functionally to drive product improvements.
  • Review complaints critically and initiate necessary corrective actions.
  • Conduct complaint risk assessment in a timely manner by reviewing complaints against product risk analysis.
  • Demonstrate expertise by leading cross-functional teams to identify risks, implement risk control measures, and document a robust and living Risk Management File.
  • Assure products meet regulatory requirements for Risk Management, including FDA QSR, MDD, EU MDR, CMDR, ISO 13485, ISO 14971 and Philips procedures

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.
  • Bachelor of Science in Engineering or a related field.
  • Knowledge of ISO 14971.
  • Knowledge of 21 CFR 803, 806, and 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.
  • Experience working within a Quality Management System.
  • Excellent team work skills including influencing and building rapport with internal customers and stakeholders.
  • Proficiency with Microsoft Excel and Word.
  • Experience working with PLM systems (e.g. Windchill), statistical software and complaint management tools.

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 .

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.

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.

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