Quality Engineering Manager

The company

Electric vehicle battery trays and enclosures are a growing product line. Most supervisors started on the line.

Overview

Medical device company seeking a Quality Engineering Manager for CAPA, nonconformance and validation work under ISO 13485. The work is on site and cannot be done remotely.

Job duties

Review and approve PPAP submissions from suppliers. Run MSA and gauge R&R studies. Respond to customer complaints and write 8D reports. Validate processes through IQ, OQ and PQ. Develop control plans, inspection plans and PFMEAs with manufacturing. Support customer and registrar audits. Conduct internal and supplier audits against ISO 9001, AS9100 or IATF 16949.

Who you are

8+ years of quality engineering experience in manufacturing. Bachelor's degree in engineering or a related technical field. Hands-on with root cause tools: 8D, fishbone, 5 Whys. Proficient in Minitab or similar statistical software.

Nice to have

ASQ CQE certification. FDA 21 CFR 820 experience. CMM programming or metrology background.

Schedule: Monday to Friday, 7:30 AM to 4:30 PM

What we offer

Pay range: $139,000 to $178,000/year. Final offer will depend on experience.

Medical, dental and vision insurance. 401(k) with a 100% match up to 5%. Paid holidays. Cell phone reimbursement. Professional development budget. Paid sick leave.

Start dates are flexible, usually within a few weeks of an offer.

Start: Immediately.

Demo job created on 11jobs for testing and demonstrations. It is not an actual opening at Pacific Automotive.