Senior Quality Engineer
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
- 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
- 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