Job Description
Job Description
SUPPLIER QUALITY ENGINEER
Onsite ~ Salt Lake City, UT
Own the supplier quality program end to end for a growing medical device
manufacturer. You'll be the quality voice to our supply base — deciding who
makes the Approved Supplier List, running the audits, and driving corrective
action when parts don't meet spec. If you want real authority (including the
ability to stop production when something's wrong) and want your decisions to
matter, this is that role.
WHAT YOU'LL OWN
- The Approved Supplier List (ASL): adds, removals, status changes, and
scheduled reviews
- Supplier onboarding and qualification: risk assessments, quality agreements,
initial audits/evaluations, and documentation review
- Supplier audits, onsite and remote — planned, conducted, and documented
against internal procedures and applicable regulatory standards
- Supplier scorecards and performance metrics (PPM, on-time response, escapes,
trend data), plus the corrective and improvement actions that follow
- Supplier Corrective Action Requests (SCARs) and supplier-related NCRs: root
cause analysis, corrective action verification, and effectiveness checks
- Disposition of nonconforming material (use-as-is, rework, scrap,
return-to-vendor) with Supply Chain, Manufacturing, and Quality
- Compliance of supplier processes with FDA QSR (21 CFR 820), ISO 13485, and
internal QMS requirements; support for internal, external, and regulatory audits
- Review and approval of supplier documentation: inspection plans,
specifications, and supplier change notifications
- Analysis of supplier and incoming inspection data to catch trends and systemic
issues, using SPC, CpK, Gage R&R, and Pareto
- Partnership with Supply Chain, Manufacturing Engineering, R&D, and Regulatory
to resolve issues and reduce supply-base risk
- Guidance and training for Quality Inspectors and Operations on inspection
requirements and supplier-related defect identification
- Authority to stop production or hold material on supplier nonconformances, and
to escalate critical issues to Quality Management
WHO YOU'LL WORK WITH
Internally: Quality, Manufacturing, Supply Chain, R&D, and Receiving Inspection.
Externally: suppliers, contract manufacturers, auditors and regulatory bodies,
and key clients.
WHAT YOU BRING
Required:
- Bachelor's degree in Engineering, Quality, or a related technical field — OR an
equivalent combination of education and relevant experience
- Hands-on experience in Quality Engineering, Supplier Quality, or Manufacturing
Quality within a regulated industry
- Working knowledge of FDA 21 CFR 820, ISO 13485, and ISO 14971
- Experience leading supplier audits, supplier onboarding, and SCAR
investigations using structured root cause methods (5 Whys, Fishbone, 8D)
- Familiarity with statistical and quality tools: SPC, CpK, Gage R&R, Pareto, FMEA
- Proficiency with Microsoft Office (Word, Excel, Outlook) and quality data
analysis tools (Minitab a plus)
- Comfort working independently and managing several supplier issues in parallel
while hitting deadlines
Preferred:
- 3+ years of supplier quality experience in medical device or another
FDA-regulated environment, including SCAR management, supplier audits, and ASL
ownership
- ASQ certification (CQE, CQA, or CSQE), or actively working toward one
- ISO 13485 Lead Auditor certification
THE WORK ENVIRONMENT
- Setting: office, clean-room, and controlled environments
- Travel: roughly 1–2 supplier audits per month, domestic and international
- Physical: primarily light work, with occasional medium work during supplier
visits and material inspection — standing, walking, sitting, reaching,
grasping, and repetitive motion, with or without reasonable accommodation
- Visual: close vision, color vision, depth perception, and the ability to adjust
focus, with or without reasonable accommodation