Supplier Quality Engineer

Peritia is partnering with a growing medical device manufacturer to hire a Supplier Quality Engineer. The company relies on outside suppliers for key components and does final assembly in-house, so this role is about quality at the source. You’ll make sure every part coming through the door meets the standard their devices and patients depend on.

What You’ll Do

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• Qualify new suppliers and maintain the Approved Supplier List, including supplier assessments and risk classification
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• Plan and conduct supplier audits, both on-site and remote, and track findings through closure
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• Lead supplier non-conformance investigations and manage SCARs, checking the supplier’s root cause and confirming their fix worked
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• Support First Article Inspections and part qualification
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• Set up and maintain supplier quality agreements
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• Define and improve incoming inspection requirements and AQL sampling plans with Receiving Inspection
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• Track supplier performance through scorecards and trending, and lead supplier performance reviews
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• Review supplier change notifications and assess their impact on product and regulatory status
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• Support supplier process validation (IQ/OQ/PQ) and review supplier validation documentation
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• Partner with Supply Chain and Engineering on supplier selection, specs, drawings and tolerances
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• Be the purchasing controls expert during internal, Notified Body and FDA 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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• 3–5+ years of quality engineering experience in medical device, pharma or another regulated manufacturing industry, including at least 2 years in supplier quality
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• Working knowledge of FDA QMSR (21 CFR 820) purchasing controls, ISO 13485 and ISO 14971
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• Hands-on experience running supplier audits and managing SCARs
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• Root cause analysis and CAPA experience (5 Whys, fishbone, 8D)
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• Ability to read engineering drawings, including GD&T
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• Strong communication and relationship skills with suppliers and internal teams
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Nice to Have

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• ASQ CQA or CQE, or ISO 13485 Lead Auditor certification
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• Experience with machined, molded or electromechanical components
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• SPC, Cpk, Gage R&R and Minitab
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• Experience with sterilization or packaging suppliers
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• EU MDR exposure
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• eQMS experience (MasterControl, Greenlight Guru or similar)
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• Lean / Six Sigma training
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Details

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• Full-time, exempt
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• onsite 5 days a week in Charlotte, NC
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• Travel of about 10–15% for supplier audits and visits
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