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.

1. Supplier Performance Monitoring and Reporting

• Collect, analyze, and report on monthly supplier performance data, including quality, delivery, and service metrics.
• Prepare and distribute supplier report cards in a standardized format to internal stakeholders and suppliers.
• Maintain and update monthly supplier statistics to monitor trends and identify areas for improvement.

2. Supplier Change Notifications (SCNs)

• Evaluate and manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.
• Coordinate cross-functional teams to assess and mitigate risks associated with supplier changes.

3. Nonconforming Material Request (NCMR) Process and Analysis

• Initiate and Document NCMRs: Identify and document nonconforming material detected during incoming inspection, production, or customer complaints. Ensure accurate logging of issue details, affected part numbers, quantities, and supplier information.
• Data Analysis and Trend Reporting: Analyze NCMR data to identify recurring issues, high-risk suppliers, and common failure modes. Generate trend reports and dashboards to communicate findings and support supplier development strategies.
• Continuous Improvement and Risk Mitigation: Drive continuous improvement by using NCMR trends to inform supplier audits, SCARs, and improvement plans. Escalate critical issues through appropriate channels, ensuring long-term risk mitigation and product quality assurance.

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

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

·       Proven experience with ISO 9001 audits and supplier quality management.

·       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, non-contributory pension, generous PTO, partial compensation on your personal health insurance and flexible working hours. But most importantly Repligen offers you a stimulating, collaborative environment with steep learning curves and the opportunity to contribute to the healthcare of patients worldwide. All of this with an international team in Waltham, MA.