Supplier Development Quality Engineer

Make Supplier Excellence Your Craft

Each Tuesday through Thursday, you’re onsite in Waltham, MA, walking the production floor, sitting shoulder-to-shoulder with Sourcing and Engineering, and holding suppliers accountable. Mondays and Fridays, you’re remote—closing out SCARs, trending NCMRs, and prepping an audit plan. You report to the Senior Manager of Supplier Quality and collaborate within a tight-knit team of three quality pros driving performance across a global supply base.

Work Setup & Logistics

• Location: Waltham, MA (Hybrid)
• Onsite: Tuesday–Thursday | Remote: Monday & Friday
• Hours: 8:30 a.m. – 5:00 p.m.
• Travel: Occasional trips to Marlborough, MA, plus supplier-site audits as needed
• Contract: 6 months with a strong likelihood of a 6-month extension based on performance, attendance, and team needs
• Compensation: $50–$60/hr, W2 only

Your Impact

You’ll ensure suppliers consistently meet quality standards, regulatory obligations, and internal specifications, blending engineering know-how with rigorous auditing to prevent issues before they surface.

What You’ll Do

• Supplier Development: Identify capability gaps with key and critical suppliers; drive continuous improvement and align with Sourcing on strategic performance goals.
• Supplier Change Notifications (SCNs): Coordinate cross-functional reviews, assess risk, document impacts, and safeguard compliance and quality during supplier-driven changes.
• Qualifications: Technically assess and qualify new and existing suppliers for process capability, compliance, and alignment to engineering and quality requirements.
• SCAR Leadership: Initiate and manage Supplier Corrective Action Requests; standardize closure timelines, ensure robust root cause quality, and prioritize high-risk issues for executive attention in partnership with Procurement.
• NCMR Ownership: Lead the Non-Conforming Material process—triage, investigate, and close; reduce recurrence through trend analysis, supplier feedback loops, and CAPA integration; escalate high-risk or repeat issues with Procurement and Supplier Quality leadership.
• Performance Management: Build and maintain supplier scorecards (quality, delivery, cost, service) and collaborate on improvement roadmaps.
• ASL Stewardship: Keep Repligen’s Approved Supplier List current by qualifying and requalifying suppliers based on results and performance.
• Auditing: Plan and execute on-site and remote supplier QMS/process audits; deliver clear reports with risk assessments and actionable recommendations.
• Risk Assessments: Evaluate supplier risk to quality, compliance, and continuity; create and monitor mitigation strategies with an emphasis on high-risk suppliers.
• Validation Support: Contribute to product and process validation activities: FAIs, capability studies, and engineering evaluations.
• Regulatory Alignment: Ensure supplier adherence to FDA, GMP, and related standards; partner with internal compliance teams to maintain alignment.
• Cross-Functional Liaison: Connect Quality, Procurement, Engineering, and Regulatory to enable cohesive supplier strategies and decisions.

What You Bring

• Bachelor’s degree in Engineering, Quality, or a related technical discipline
• 5–7+ years in supplier quality engineering, manufacturing engineering, or quality assurance
• Hands-on supplier QMS and process auditing experience (ISO 9001)
• Proficiency in root cause analysis and corrective/preventive action methodologies
• Experience performing risk assessments and quality audits; comfort with eQMS or digital audit tools
• Working knowledge of FDA, GMP, and related regulatory frameworks
• Clear communicator, skilled negotiator, and effective collaborator
• Willingness to travel for supplier audits and evaluations

Join a fast-paced, collaborative environment where your work directly shapes supplier accountability and product reliability.