Make a global impact—join Repligen.
We’re united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. No matter your role or background, at Repligen, you will play a key part in shaping some of the most innovative and life-changing therapies in the world. We foster a culture of purpose, collaboration, and shared success—where every voice matters and every contribution drives progress. Join us!

We are seeking a Supplier Quality Engineer to join our growing Supplier Quality team. You will a key role in ensuring the quality, compliance, and performance of Repligen’s global supplier base. This is an opportunity to contribute to meaningful work on cutting-edge projects in a fast-paced, collaborative environment. You will be part of a cross-functional team of 3 highly motivated and collaborative professionals responsible for managing supplier qualification, risk mitigation, and quality performance. The team plays a key role in driving supplier accountability, supporting root cause investigations, and ensuring Repligen’s supplier network meets regulatory and quality standards. This role is based in Waltham, MA, and will report to the Senior Manager of Supplier Quality.

Responsibilities:

The Supplier Quality Engineer (SQE) will be responsible for ensuring that Repligen’s suppliers meet all quality standards, regulatory requirements, and internal specifications. This role combines engineering expertise with auditing skills to oversee supplier performance, conduct audits, and drive continuous improvement initiatives. The SQE will work closely with suppliers to resolve quality issues, implement corrective actions, and develop strategies for risk mitigation.

Key Responsibilities:

• Support supplier development programs by identifying capability gaps and enabling continuous improvement plans with key and critical suppliers. Partner with Sourcing to align on strategic supplier performance.
• Supplier Change Notifications (SCNs): Evaluate and manage Supplier Change Notifications, ensuring that all changes are documented, reviewed, and analyzed for impact on quality and compliance. Coordinate cross-functional review teams to assess the potential risks of supplier changes.
• Supplier Qualifications: Conduct technical evaluations and qualifications for new and existing suppliers. This includes reviewing supplier manufacturing processes, capabilities, and compliance with Repligen’s engineering and quality requirements.
• Supplier Corrective Action Requests (SCARs): Initiate and manage SCARs to address non-conformances identified during audits or routine quality checks. Work with suppliers to implement effective corrective and preventive actions, conducting follow-up audits to verify the effectiveness of actions taken.  Standardize and drive accountability in SCAR closure timelines and root cause quality. Implement risk-based SCAR prioritization to ensure critical issues receive senior-level supplier attention. Collaborate with Procurement to reinforce supplier performance expectations.
• Non-Conformance Material Reports (NCMRs): Manage the NCMR process, ensuring timely identification, documentation, and resolution of non-conforming materials from suppliers. Collaborate with suppliers to investigate root causes and implement corrective actions to prevent reoccurrence.   Lead efforts to reduce repeat NCMRs through trend analysis, supplier feedback loops, and CAPA integration. Coordinate with internal teams to ensure timely disposition of materials and closeout of NCMRs. Own the escalation process for high-risk or recurring NCMRs with Procurement and Supplier Quality leadership.
• Supplier Performance and Scorecards: Develop and maintain supplier scorecards to monitor performance on key metrics, including quality, delivery, cost, and service. Collaborate with suppliers to identify areas of improvement based on performance trends.
• Approved Supplier List (ASL) Maintenance: Ensure that Repligen’s Approved Supplier List (ASL) is regularly updated to reflect current supplier status. Work cross-functionally to qualify and requalify suppliers based on quality performance and audit results.
• Conduct Supplier Audits: Plan and perform on-site and remote audits of suppliers to evaluate their quality management systems, production processes, and adherence to engineering specifications. Provide detailed audit reports, including risk assessments and recommendations for improvement.
• Conduct Risk Assessments: Perform supplier risk assessments to evaluate the likelihood and impact of potential risks to quality, regulatory compliance, and supply chain reliability. Develop and monitor risk mitigation strategies, especially for high-risk suppliers.
• Continuous Improvement Initiatives: Partner with suppliers to drive continuous improvement in quality, cost, and delivery. Use root cause analysis, statistical tools, and engineering methods to help suppliers optimize their processes and products.
• Product and Process Validation: Assist in the validation of supplier processes and products, including first article inspections, process capability studies, and engineering evaluations. Ensure that all supplier-provided materials and components meet Repligen’s technical and quality specifications.
• Compliance with Regulatory Standards: Ensure supplier adherence to industry regulations (FDA, GMP, etc.) and maintain up-to-date knowledge of applicable regulatory and quality standards. Collaborate with the internal compliance team to align supplier practices with Repligen’s regulatory obligations.
• Act as a liaison between Quality, Procurement, Engineering, and Regulatory functions to ensure cohesive supplier strategies and decisions.

·         Bachelor’s degree in engineering, Quality, or related technical field.

·         5-7+ years of experience in supplier quality engineering, manufacturing engineering, or quality assurance.

·         Supplier QMS & Process auditing experience (ISO 9001)

·         Strong problem-solving skills, including root cause analysis and corrective action methodologies.

·         Proficiency in conducting risk assessments and quality audits.

·         Experience with eQMS systems or digital audit tools

·         Familiarity with regulatory standards (FDA, GMP, etc.).

·         Excellent communication, negotiation, and interpersonal skills.

·         Willingness to travel for supplier audits and evaluations.

Repligen offers you a competitive remuneration package, including a yearly bonus, private medical insurance and flexible working hours. But most importantly Repligen offers you a stimulating, fast-paced environment with steep learning curves and the opportunity to contribute to the healthcare of patients worldwide. All of this with an international team in Waterford, Ireland.