Repligen
Supplier Quality Engineer
Repligen, Marlborough, Massachusetts, us, 01752
Overview:The Supplier Quality Engineer (SQE) as part of the team 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:Supplier Performance and Scorecards:
Develop and maintain supplier (ASL) 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.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 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.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.Quality Audits:
Lead Assessor for ISO 9001: Serve as the primary lead for supplier audits, specifically ISO 9001 compliance. Ensure that suppliers adhere to all ISO 9001 standards, performing detailed audits, and collaborating with suppliers to address findings.Qualifications:Bachelor’s degree in engineering, Quality, or related technical field.5-7+ 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.Familiarity with regulatory standards (FDA, GMP, etc.).Excellent communication, negotiation, and interpersonal skills.Willingness to travel for supplier audits and evaluations.
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Develop and maintain supplier (ASL) 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.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 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.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.Quality Audits:
Lead Assessor for ISO 9001: Serve as the primary lead for supplier audits, specifically ISO 9001 compliance. Ensure that suppliers adhere to all ISO 9001 standards, performing detailed audits, and collaborating with suppliers to address findings.Qualifications:Bachelor’s degree in engineering, Quality, or related technical field.5-7+ 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.Familiarity with regulatory standards (FDA, GMP, etc.).Excellent communication, negotiation, and interpersonal skills.Willingness to travel for supplier audits and evaluations.
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