What are the responsibilities and job description for the Supplier Quality Engineer position at Astrix?
Our client is a leading life sciences company that develops and manufactures tools and materials used in the production of biologic drugs. They are looking for a skilled Supplier Quality Engineer to join their growing team In Middlesex County, MA! This is a great opportunity to contribute to an innovative life science organization!
Location: Middlesex County, MA
Job type: $55/hr. - $58/hr.
Job type: 6-month contract
Format: Hybrid schedule
Responsibilities
Location: Middlesex County, MA
Job type: $55/hr. - $58/hr.
Job type: 6-month contract
Format: Hybrid schedule
Responsibilities
- Support supplier development initiatives by identifying capability gaps and driving continuous improvement plans with key suppliers
- Evaluate and manage Supplier Change Notifications (SCNs), including risk and impact assessments
- Conduct supplier qualification and requalification activities for new and existing suppliers
- Initiate, manage, and close Supplier Corrective Action Requests (SCARs)
- Lead investigations into supplier non-conformances and implement corrective/preventive actions
- Manage Non-Conforming Material Reports (NCMRs) and coordinate material disposition activities
- Perform supplier audits (onsite and remote) to assess compliance with quality and regulatory standards
- Develop and maintain supplier scorecards to monitor quality, delivery, cost, and service metrics
- Maintain the Approved Supplier List (ASL) and ensure supplier compliance status is current
- Conduct supplier risk assessments and develop mitigation strategies for high-risk suppliers
- Partner with suppliers to drive continuous improvement in quality, delivery, and process performance
- Ensure supplier compliance with FDA, GMP, ISO 9001, and internal quality requirements
- Bachelor’s degree in Engineering, Quality, or a related technical discipline
- 7 years of experience in Supplier Quality Engineering, Manufacturing Engineering, or Quality Assurance
- Strong experience conducting supplier audits and Quality Management System (QMS) assessments
- Working knowledge of ISO 9001 standards and auditing practices
- Experience with SCARs, CAPA, root cause analysis, and non-conformance management
- Familiarity with FDA, GMP, and regulated manufacturing environments
- Proficiency in supplier risk assessment and mitigation strategies
- Experience using eQMS systems or digital quality/audit tools
- Strong analytical and problem-solving abilities
- Excellent communication, negotiation, and stakeholder management skills
Salary : $55 - $58