Manager, Sustaining Quality Assurance
Job TitleManager, Sustaining Quality Assurance
We are finding innovative ways using cutting edge technologies to increase patient safety, reduce risks, and improve how healthcare is delivered. Our Design Assurance Team tackles these very challenges. As a member of the team, you will help ensure that every new medical device product is developed meeting the requirements of our market's regulatory bodies. You will work through all phases of product development from idea rollout into production and future design improvements; the entire PDLC of a medical device. This position is a "Working Manager" position, in addition to the management of two staff members the position requires individual contributions as described below.
- Manage a team of two to three individuals focused on Sustaining Quality Assurance activities including:
- Complaint Analysis and Reporting
- Updating the Risk Management System
- Executing and documenting Post Market Surveillance
- Support Companywide Microbiology/Sterilization strategy and deployment
- Support Key Tool user support and training for infrastructure tool sets such as Windchill, SAP, etc.
- Provide strategic compliance decisions and direction to teams, functions and/or the organization with very little supervision or oversight
- Be a prime technical contact leveraging your wide ranging experience and demonstrated knowledge and understanding of quality engineering
- Team with the Design Assurance to ensure Quality Engineering support across the full product lifecycle.
- Responsibilities expand beyond individual projects to cross project consistency in the application of high quality/compliant post-market Quality Assurance practices.
- Develop and implement new and improved quality/compliant post-market methods, techniques and processes.
- Apply advanced technical principles, theories, and concepts. Contribute to the development of new principles and concepts. (Multi-discipline, multi-domain, systems).
- Execute complex CAPAs, perform or contribute to root cause investigations of commercialized product.
- Facilitate Risk Management File creation and updates
- Provides input on various levels of projects and client requests. Independently determine and develop solution approaches
- Bachelor's degree in Mechanical, Electrical, Biomedical, Industrial, Material Science or Chemical Engineering.
- 12+ years in Quality Engineering; 6+ years preferably in the medical device industry.
- Excellent analytical skills with experience in Medical Device/FDA regulated industry
- Understanding of theories and principles of Design Controls, Product Life Cycle, Risk Management and 21 CFR part 820.
- Demonstrated ability to work collaboratively in a cross-functional, cross-discipline environment
- Ability to organize and prioritize workflow in order to meet established time frames and schedules.
- Experience with Microsoft© Windows operating system
This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that's not all. Quality is right on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role's mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.
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Ready to start improving lives by putting your personal skills & passions to work? Apply Today!
Find out more info about Philips at www.philips.com/na/careers
Philips is an equal opportunity employer
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
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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Jose engineers the specific system level requirements for the Philips Sonicare oral healthcare products. He makes certain the detailed design of each device over-delivers on customer expectations every time.
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