Quality Engineer II - Medical Device

Peritia is partnering with a growing medical device manufacturer to hire a Quality Engineer II. This is a permanent, direct-hire role focused on supporting manufacturing. You’ll lead the QC inspection team, partner with Operations and Engineering, and help reduce rework and increase throughput in a regulated FDA / ISO 13485 environment.

What You’ll Do

• Lead the QC inspection team day to day, including priorities, workload and inspection standards
• Own non-conformance investigations from start to finish, working with line operators and inspectors to find causes and put effective fixes in place
• Lead CAPAs using structured root cause analysis (5 Whys, fishbone, DMAIC), and use data to confirm the root cause and that the fix worked
• Drive projects that reduce NCs and rework and improve efficiency, such as cutting QC inspection time
• Trend quality data and metrics using Pareto charts, control charts / X-bar R and normalized data
• Partner with production leadership to improve how well the floor follows work instructions and keeps up batch records and GMP documentation
• Write and update Work Instructions and Work Aides with Sustaining Engineering (poka-yoke, 5S)
• Write and review IQ/OQ/PQ protocols, pFMEAs and control plans
• Support AQL sampling, incoming inspection, supplier quality and audits

What You Bring

• Bachelor’s degree in engineering or a related STEM field, or equivalent experience
• 3–6 years of quality engineering experience in medical device or pharmaceutical manufacturing
• Hands-on experience supporting manual assembly or production processes
• Proven NC and CAPA experience, with a data-driven approach to root cause
• Working knowledge of FDA QMSR (21 CFR 820), ISO 13485 and ISO 14971
• Experience with process validation (IQ/OQ/PQ), pFMEAs and control plans
• Strong communication skills, with the ability to connect respectfully with everyone from line operators to directors and auditors

Nice to Have

• Experience with both manual and automated manufacturing
• Minitab, SPC, Gage R&R and capability analysis
• Lean / Six Sigma (Green Belt or ASQ CQE a plus)
• Prior lead or supervisory experience with inspectors or technicians
• Experience with sterilization and packaging validation, supplier audits or EU MDR

Details

• Full-time, exempt, direct hire
• On-site, Charlotte, NC
• Travel under 10%