Quality Engineer II - Medical Device

Job Description

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

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

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

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

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