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%
Quality Engineer II - Medical Device in Charlotte at Peritia
This position is listed as full time and onsite. It was posted 4 days ago.