AuST Group is a rapidly growing medical device design house and manufacturing facility, with an innovative and energetic team committed to improving patient outcomes through high-quality products and cutting-edge technology. We are committed to maintaining the highest standards of quality and compliance in all our operations.
Job Summary
Supplier Quality Engineer
We are seeking a motivated and detail-oriented Supplier Quality Engineer to join our medical device quality team. This role is focused on managing and developing our supplier quality program in alignment with ISO 13485, FDA 21 CFR 820, and internal quality system requirements. The Supplier Quality Engineer serves as the primary point of contact for supplier quality activities, ensuring that purchased components, materials, and services consistently meet established quality and regulatory requirements.
This position requires a hands-on, detail-oriented approach to supplier oversight, nonconformance management, and cross-functional collaboration to protect incoming material quality and drive continuous improvement within the supply base.
Key Responsibilities
- Supplier Audits: Plan, schedule, and conduct on-site and remote supplier audits (process audits, system audits, and for-cause audits) in accordance with ISO 13485 and the company’s Approved Supplier List (ASL) program. Document audit findings, issue nonconformance reports, and verify effectiveness of supplier corrective actions.
- SCAR Management: Issue, track, and close Supplier Corrective Action Requests (SCARs) in response to incoming inspection rejections, field complaints, or audit findings. Evaluate supplier root cause analysis (8D, 5-Why, Fishbone) and corrective action plans for technical adequacy, and monitor closure within defined timelines. Escalate repeat or high-risk SCARs to management as appropriate.
- Incoming Inspection & NC Investigations: Support and oversee incoming inspection activities. Lead investigations of incoming nonconformances (NCs), determine disposition (use-as-is, rework, return to vendor), and drive supplier notifications and containment actions.
- Supplier Onboarding & Qualification: Manage the supplier qualification process for new and existing suppliers, including completion of supplier questionnaires, quality agreements, risk classification, and initial audit or desk evaluation. Maintain and update the Approved Supplier List (ASL) in compliance with ISO 13485.
- Supplier Scorecards & Performance Monitoring: Develop and maintain supplier scorecards tracking key performance indicators (KPIs) such as on-time delivery, incoming rejection rate, SCAR response timeliness, and audit results. Communicate scorecard results to suppliers and internal stakeholders on a periodic basis, and facilitate supplier performance reviews as warranted.
- Quality Agreements: Draft, review, and maintain Supplier Quality Agreements that define quality, regulatory, and documentation expectations for critical and major suppliers, in alignment with ISO 13485 requirements.
- First Article Inspection (FAI) & Part Qualification: Coordinate and review First Article Inspections (FAIs) and dimensional/functional reports for new or changed purchased components. Evaluate supplier-submitted documentation packages (CoCs, CMM reports, material certifications) for completeness and compliance.
- Change Control & Supplier Notifications: Review and evaluate supplier change notifications for potential impact to product quality, regulatory compliance, and validation status. Coordinate with Engineering and Regulatory Affairs to ensure appropriate risk assessment and approval prior to implementation.
- Risk-Based Supplier Oversight: Apply risk-based thinking per ISO 14971 and ISO 13485 to classify suppliers by criticality, determine audit frequency, and set inspection sampling levels. Participate in supplier risk assessments when new components or suppliers are introduced.
- Data Analysis & Continuous Improvement: Analyze supplier quality data and incoming inspection trends to identify systemic issues and drive proactive improvement initiatives. Apply quality tools such as Pareto analysis, SPC, CpK, and trend charting to evaluate supplier process capability and stability.
- Documentation & Quality System Compliance: Maintain accurate and audit-ready supplier quality records including audit reports, SCARs, qualification packages, scorecards, and QAAs. Support management reviews, internal audits, and regulatory inspections (FDA, Notified Body) with supplier quality data and documentation.
- Cross-Functional Collaboration: Partner with Procurement, Engineering, Regulatory Affairs, and Manufacturing to communicate supplier quality status, support new product introductions (NPI), and resolve material disposition issues in a timely manner.
- Perform other duties as assigned by Quality Management, consistent with the employee’s experience, training, and level of responsibility.
Qualifications
- Bachelor’s degree preferred in Engineering, Supply Chain, Quality, or a related technical field.
- If no degree, 2–5 years of relevant experience in supplier quality, incoming inspection, or quality engineering within a regulated medical device or life sciences environment.
- Working knowledge of ISO 13485 (Section 7.4 – Purchasing), FDA 21 CFR 820.50, and ISO 14971 as applied to supplier oversight and risk management.
- Experience conducting or supporting supplier audits, issuing SCARs, and evaluating supplier corrective action responses using structured root cause analysis tools (8D, 5-Why, Fishbone/Ishikawa).
- Strong analytical and problem-solving skills; experience in Excel, Minitab, or similar tools for quality data analysis and supplier performance trending.
- Excellent written and verbal communication skills, with high attention to detail.
- Demonstrated ability to work collaboratively in cross-functional environments.
- Preferred Qualifications
- Experience conducting ISO 13485 supplier audits (on-site or remote), including audit planning, report writing, and SCAR issuance.
- Familiarity with ANSI/ASQ Z1.4 sampling standards and incoming inspection plan development.
- Experience managing supplier scorecards, performance metrics, and supplier performance reviews.
- Certified CQE, CQA, ISO 13485 Lead Auditor, or similar qualification (or actively working toward certification).
- Proficiency in data analysis, gage R&R, or SPC methods as applied to supplier process capability evaluation.
- Experience with First Article Inspection (FAI), supplier qualification documentation, and quality agreement management.
Position Leveling Overview
- The Supplier Quality Engineer independently manages defined supplier quality activities—such as routine audits, SCAR processing, and incoming inspection oversight—under general supervision from a Senior SQE or Quality Manager.
- Demonstrates ability to interpret and apply ISO 13485 supplier control requirements and translate them into practical supplier oversight activities.
- Takes ownership of SCARs, supplier audits, incoming NC investigations, and supplier onboarding activities with support from senior engineers or quality management.
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Education:
Ability to Relocate:
- West Valley City, UT 84119: Relocate before starting work (Required)
Work Location: In person
