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Senior Quality Engineer

Description

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.

Phillips-Medisize LLC is seeking a Sr. Quality Engineer to ensure quality requirements are met per customer specifications through statistical analysis and proactive problem solving using current lean/six sigma tools, processes and systems ensuring effective root cause determination and corrective action.

What You Will Do In Your Role

  • Implement systems and procedures that assure compliance with Quality Standards.
  • Develop and implement statistical incoming and in-process sampling/control plans.
  • Participate in initial process development, Design for Manufacturing and Design for Assembly and support validation with (Cpk, SPC, t-tests, OC Curves, sample size, Minitab).
  • Interfaces with engineering, operations, customer, and vendor representatives to ensure all requirements are met.
  • Use statistics to assess product performance data solve and complex manufacturing quality problems.
  • Investigate of out of specification product dimensions to determine if there is impact to released product to include:
  • Lead & perform full CAPA process from containment to corrective action to prevent recurrence
  • Write technical reports in support of NCMR investigations and CAPA
  • Manage MRB product dispositions
  • Manage the Supplier qualification process; lead corrective actions relating to supplier performance; improve process for supplier data submission to reduce internal inspections.
  • Assist with third party and FDA quality audits as needed.
  • Responsible for leading change control teams to ensure changes to processes and equipment do not impact product quality or the validated state.
  • Facilitate communication between engineering, manufacturing, and quality.
  • A communication liaison between the customer and manufacturing facility.
  • Some travel to other facilities may be required to support business needs.
  • Some programs may have vision requirements.

The Experience You Will Bring

Requirements:

  • Bachelor's Degree in Engineering or associated scientific discipline required
  • Clear and concise verbal, written skills including to external customers
  • Clear and concise presentation of data to groups including customers, leadership and sales
  • Demonstrated application of structured problem-solving methods and tools
  • Demonstrable application of project planning & management

What Will Put You Ahead

  • 6+ years engineering experience in a quality/regulatory environment; FDA 21CFR80.820, ISO13485 preferred
  • DFSS or DMAIC Black Belt Certified or Certified Quality Engineer (CQE) preferred

This position does not qualify for VISA sponsorship

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

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