Supplier Quality Engineer

RepliGen Corporation; Hopkinton (MA); On-site; USD 80,000 - 105,000; Full time

Benefits offered by this job

Paid time off

Health/dental/vision insurance

Retirement benefits

Job summary

Repligen is seeking a Supplier Quality Engineer to join the Global Supplier Quality team in Massachusetts. You will evaluate supplier processes, lead audits, and drive CAPA/SCAR activities to ensure GMP and FDA compliance across the supplier network.

The role requires 2+ years in supplier quality or related fields, with strong analytical and communication skills, and willingness to travel to supplier sites. Hybrid or on-site work in MA preferred.

Qualifications

• Bachelor's degree in a technical discipline (Engineering, Quality, Life Sciences) or equivalent experience.
• 2+ years of experience in Supplier Quality, Quality Engineering, or related field.
• Experience with supplier qualification, supplier audits, nonconformance investigations, CAPA/SCAR, and root cause analysis.

Responsibilities

• Perform supplier qualification activities, evaluating processes, quality systems, and regulatory compliance.
• Plan and conduct supplier audits; document findings and drive corrective actions.
• Lead supplier-related nonconformance investigations and SCARs with root cause analysis.
• Evaluate supplier change notifications and coordinate cross-functional reviews.
• Monitor supplier performance using scorecards, NCMRs, SCARs, and audits.
• Collaborate with Quality, Sourcing, Engineering, Operations, and Regulatory teams.

Skills

Problem solving

Analytical skills

Communication

Cross-functional collaboration

Education

Bachelor's degree in Engineering/Quality/Life Sciences or related

Job description

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 highly motivated and collaborative professionals responsible for managing supplier qualifications, 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 or Hopkinton MA and will report to the Senior Director of Global Supplier Quality.Key ResponsibilitiesSupplier Qualification: Conduct technical evaluations and qualification activities for new and existing suppliers, including assessment of manufacturing processes, capabilities, quality systems, and compliance with Repligen requirements.Supplier Audits: Plan and conduct supplier audits, document findings, assess risk, and follow through on corrective actions and improvement opportunities.Supplier Quality Issues: Lead supplier-related nonconformance investigations and Supplier Corrective Action Requests (SCARs), including root cause evaluation, corrective action follow-up, and effectiveness verification.Supplier Change Management: Evaluate Supplier Change Notifications (SCNs), assess quality and regulatory impact, and coordinate cross-functional reviews and required actions.Supplier Performance: Monitor supplier quality performance and trends through scorecards, NCMRs, SCARs, audit results, and other key performance indicators. Partner with suppliers to address performance gaps.Supplier Risk and Development: Perform supplier risk assessments and support development plans for key and critical suppliers to reduce quality and supply risk and improve supplier capability.Cross-Functional Partnership: Collaborate with Quality, Sourcing, Engineering, Operations, and Regulatory teams on supplier qualification, product and process validation, supplier changes, and quality improvement activities.QualificationsBachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline, or equivalent relevant experience.2+ years of experience in Supplier Quality, Quality Engineering, Manufacturing Quality, or a related field.Experience with supplier qualification, supplier audits, nonconformance investigations, CAPA/SCAR, and root cause analysis.Working knowledge of quality management systems and applicable regulatory requirements, including GMP and FDA requirements.Ability to evaluate manufacturing processes, technical documentation, and supplier quality systems.Strong problem-solving, analytical, communication, and cross-functional collaboration skills.Ability to travel to supplier locations as required.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 salary range for this role, based in the United States of America is $80,000-$105,000. 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.