Quality Engineer 2

Job Title

Quality Engineer 2

Job Description

In this role, you have the opportunity to
Execute as a Quality Engineer (Q&R) for the newly acquired Philips manufacturing facility in Minnesota. You will support site Business Units in transfer, installation and validation, beginning with a Class III combination device.

As a QE, you will develop, establish and maintain quality engineering systems, and practices which meet requirements established by Philips, customers and regulatory agencies. You will serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives. You will provide focused quality engineering support within new product development. You will maintain Risk Management documentation and provide Quality Engineering support for the life cycle of all Philips products.

You are responsible for

  • 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.
  • Support Quality Improvement projects for the site, including formal quality efforts such as CAPA, NCMR, OOS and Audit Responses.
  • Develop, implement and monitor quality metrics. Communicate status and progress.
  • Support systems for maintaining manufacturing quality (e.g. Review of equipment / records).
  • Support systems for maintaining manufacturing quality (e.g. Review of equipment / 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.

To succeed in this role, you should have the following skills and experience
  • BS in Engineering (preferred) life sciences or other related field.
  • Minimum of 2 years of work experience in the medical device or pharmaceutical industry.
  • Experience with FDA requirements 21 CFR 820, knowledge of regulations such as GLP, GMP, ISO 13485 and other international regulatory requirements.
  • Preferred experience with 21 CFR part 4 - Regulation of Combination Products and/or 21 CFR part 211 - cGMP for Finished Pharmaceuticals and EUMDR.
  • 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 . 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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