Supplier Quality Engineer Job Waltham area,Massachusetts USA,Quality Assurance

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

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

Qualifications

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

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