Philips Quality Engineer in Fremont, California

New Hire

Job Title: Quality Engineer

Position Summary:

Develops, establishes and maintains quality engineering systems, and practices which meet requirements established by Spectranetics, customers and regulatory agencies. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives. Provides focused quality engineering support within new product development. Maintains Risk Management documentation and provides Quality Engineering support for the life cycle of all Philips/Spectranetics products.

Essential Functions:

The following is meant to be a representative but not necessarily comprehensive summary of the duties and responsibilities for this position title:

  • Lead on Active Risk Management Data collection and reporting

  • Support the non-conforming material process and the Materials Review Board

  • Support problem -solving teams through root cause investigations and failure analysis to implementation and final verification.

  • Ensure Risk Management is effective utilizing feedback from validation, post market surveillance, manufacturing indicators, NCMR’s, CAPAs, HHEs, etc.

  • Develop, implement and monitor quality metrics. Communicate status and progress.

  • Support systems for maintaining manufacturing quality {e.g. Review of equipment even records).

  • Support Health Hazard Evaluations (HHEs) to ensure risk assessment and root cause analysis are consistent across products and systems.

  • Participate in the development and results analysis of validation plans {IQ/OQ/PQ) and test protocols to qualify and validate existing and new product designs and processes. Includes the use of various statistical techniques and quality tools.

  • Basic understanding of statistical techniques, including design of experiments {DOE); able to analyze results.

  • Support development of basic inspection and testing techniques; must be able to read and interpret blueprints.

  • Write and coordinate efforts for the development and implementation of new and updated Quality System procedures.

  • Generate trend reports for projects on an as­ needed basis.

  • Must be able to interface well with others.

Education and/or Experience:

  • BS in Engineering (preferred) life sciences or other related field.

  • Medical device industry (preferred).


  • Experience with FDA requirements, knowledge of regulations such as GLP, GMP, ISO 13485 and other international regulatory requirements.

  • Proficiency with statistical software package (such as Minitab and JMP).

  • ASQ CQE {Certified Quality Engineer) or CSSBB (Certified Six Sigma Black Belt) is a plus.

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 at . 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 at on our career website, where you can read stories from our employee blog at . Once there, you can also learn about our recruitment process at , or find answers to some of the frequently asked questions at .

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.