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

• Qualify new suppliers and maintain the Approved Supplier List, including supplier assessments and risk classification
• Plan and conduct supplier audits, both on-site and remote, and track findings through closure
• Lead supplier non-conformance investigations and manage SCARs, checking the supplier’s root cause and confirming their fix worked
• Support First Article Inspections and part qualification
• Set up and maintain supplier quality agreements
• Define and improve incoming inspection requirements and AQL sampling plans with Receiving Inspection
• Track supplier performance through scorecards and trending, and lead supplier performance reviews
• Review supplier change notifications and assess their impact on product and regulatory status
• Support supplier process validation (IQ/OQ/PQ) and review supplier validation documentation
• Partner with Supply Chain and Engineering on supplier selection, specs, drawings and tolerances
• Be the purchasing controls expert during internal, Notified Body and FDA audits

What You Bring

• Bachelor’s degree in engineering or a related STEM field, or equivalent experience
• 3–5+ years of quality engineering experience in medical device, pharma or another regulated manufacturing industry, including at least 2 years in supplier quality
• Working knowledge of FDA QMSR (21 CFR 820) purchasing controls, ISO 13485 and ISO 14971
• Hands-on experience running supplier audits and managing SCARs
• Root cause analysis and CAPA experience (5 Whys, fishbone, 8D)
• Ability to read engineering drawings, including GD&T
• Strong communication and relationship skills with suppliers and internal teams

Nice to Have

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

Details

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