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Quality Engineer-NPI

This job posting is no longer active.


Phillips-Medisize LLC is seeking a Quality Validation Engineer to support new product introductions, provide statistical, documentation and coordination support to ensure objectives are met throughout the entire IQ, OQ, PQ Validation process.  

What You Will Do In Your Role

  • Drafting Validation documents including FAT, SAT, IQ, OQ, PQ, PPQ and URS
  • Draft Validation reports and review attachments including Device History Records
  • Create and revise Device Master Record documents
  • Development and implementation of statistical incoming and in-process sampling/control plans
  • Use statistics to assess product performance data, solve complex manufacturing quality problems and support validation strategies (Cpk, SPC, t-tests, OC Curves, sample size, Minitab).
  • Participate in initial process development, Design for Manufacturing and Design for Assembly phases. Develops validation templates.
  • Interfaces with engineering, operations, customer, and vendor representatives to ensure all requirements are met.
  • Submit Metrology requests and analyze data
  • Facilitate meetings for PFMEAs and Control Plans
  • Provide training to production staff on validated work instructions
  • Provide updates on project status and support team meetings with customers
  • Assist with third party and FDA quality audits as needed.

The Experience You Will Bring


  • Bachelor’s Degree in an Engineering Degree required
  • Technical knowledge in injection molding required

What Will Put You Ahead

  • 6+ years quality/regulatory experience preferred
  • 3+ years auditing experience preferred
  • Thorough knowledge of CFR 21, Part 820, ISO 13485:2016 preferred
  • Ability to identify problems, and develop and implement actions to resolve them
  • Demonstrable track record of planning activities with contingency actions

About Phillips-Medisize, LLC…

Phillips-Medisize, LLC, a Molex company, is a leading global outsource provider of design and manufacturing services to the drug delivery, consumable diagnostics, medical device and specialty commercial markets.

Learn more...

Visit us: www.phillipsmedisize.com

Twitter: www.twitter.com/phillipsmedisiz

YouTube: www.youtube.com/user/PhillipsPlasticsCorp

Linkedin: www.linkedin.com/company/Phillips-Medisize

Phillips-Medisize History: www.phillipsmedisize.com/about-us/history

Salary and Benefits Commensurate with Experience.
Equal Opportunity Employer.
Except where prohibited by state law, all offers of employment are conditioned upon successfully passing a drug test.

This employer uses E-Verify. Please visit the following website for additional information: www.kochcareers.com/doc/Everify.pdf

This job posting is no longer active.

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