Supplier Quality Engineer

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

Job summary

Repligen is seeking a Supplier Quality Engineer to join the Global Supplier Quality team in the U.S. You will evaluate supplier processes, manage qualifications and audits, lead SCAR investigations, and drive corrective actions to ensure GMP/FDA compliance across the supplier base.

The role reports to the Senior Director of Global Supplier Quality and is based in Massachusetts (Waltham or Hopkinton). The successful candidate will partner with Quality, Sourcing, Engineering, and Regulatory teams,

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline.
• 2+ years in Supplier Quality, Quality Engineering, or related field.
• Experience with supplier qualification, audits, nonconformance investigations, CAPA/SCAR, and root cause analysis.
• Knowledge of GMP and FDA regulatory requirements.
• Ability to evaluate manufacturing processes and supplier quality systems.
• Strong problem-solving and cross-functional collaboration skills.

Responsibilities

• Qualifications and qualification activities for new/existing suppliers.
• Plan and conduct supplier audits and document findings.
• Lead SCAR investigations, corrective actions, and verification.
• Evaluate SCNs and coordinate cross-functional actions.
• Monitor supplier performance via scorecards and KPIs.
• Perform supplier risk assessments and development plans.

Skills

Supplier quality

Root cause analysis

Cross-functional collaboration

Communication

Analytical thinking

Travel flexibility

Education

Bachelor's degree in Engineering, Quality, Life Sciences, or related field

Tools

QMS

CAPA tools

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 Responsibilities

• Supplier 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.

Qualifications

• Bachelor'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.