Supplier Quality Engineer

Overview

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

• 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.

• 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.

• 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.

Qualifications

• Bachelor's degree in engineering, Quality, or related technical field.

• 8-10+ 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.

What Repligen Offers

Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated base salary range for this role, based in the United States of America is $105,000-161,000. Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.