Supplier Quality Engineer

Supplier Quality Engineer Astrix Technology Group - 3.4 Waltham, MA Job Details Contract $55 - $58 an hour 1 hour ago Qualifications Quality control corrective actions ISO standards Regulatory compliance Corrective and preventive actions (CAPA) Quality management GMP Risk mitigation strategy implementation Root cause analysis Negotiation FDA regulations Full Job Description 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 INDBH #LI-AH1