Supplier Quality Engineer

Peritia; Charlotte (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Peritia is partnering with a growing medical device manufacturer to hire a Supplier Quality Engineer. This role focuses on quality at the source, ensuring every part arriving through the door meets the high standards their devices require.

You will qualify suppliers, lead on-site and remote audits, investigate SCARs, support First Article Inspections, and collaborate with Supply Chain and Engineering on selections and specs. On-site in Charlotte, NC five days a week with occasional travel.

Qualifications

• Bachelor's degree in engineering or related STEM field, or equivalent experience.
• 3-5+ years of quality engineering in medical device or regulated manufacturing, including 2+ years in supplier quality.
• Working knowledge of FDA QMSR (21 CFR 820) and ISO 13485/14971.
• Hands-on supplier audits and SCAR management experience.
• Root cause analysis and CAPA (5 Whys, fishbone, 8D).
• Ability to read engineering drawings, including GD&T.
• Strong communication with suppliers and internal teams.

Responsibilities

• Qualify new suppliers and maintain the Approved Supplier List, including assessments and risk classification.
• Plan and conduct supplier audits (on-site and remote) and track findings to closure.
• Lead supplier non-conformance investigations and manage SCARs.
• Support First Article Inspections and part qualification.
• Set up and maintain supplier quality agreements.
• Define and improve incoming inspection requirements and AQL sampling plans.

Skills

Quality engineering

Supplier quality

Root cause analysis

GD&T reading

Communication with suppliers

CAPA

Education

Bachelor's degree in engineering

Tools

Minitab

Job description

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