Supplier Quality Engineer

Supplier Quality Engineer Kinetic Personnel Group, Inc.

• 2.8 Waltham, MA Job Details $110,000
• $130,000 a year 1 day ago Qualifications Technical engineering Defect resolution root cause analysis Corrective and preventive actions (CAPA) GMP ISO certification audits Quality control audit Supplier audits Regulatory/legal compliance standards in production Biomedical regulatory compliance Legal compliance Production process auditing Negotiation Pharmaceutical quality assurance Failure analysis Full Job Description We have an position for a Supplier Quality Engineer with a global life sciences manufacturer specializing in advanced bioprocessing technologies that support leading biotech and pharmaceutical organizations.

The Supplier Quality Engineer will play a key role within a growing Supplier Quality organization, ensuring the quality, compliance, and performance of a global supplier base. This role blends engineering expertise, auditing capability, and cross-functional collaboration to maintain high standards across the supply chain. You'll join a tight-knit team of three quality professionals and report directly to the Senior Manager of Supplier Quality, contributing to meaningful, cutting-edge work in a dynamic environment. Key Responsibilities Supplier Development — Identify capability gaps, drive continuous improvement, and partner with Sourcing on strategic supplier performance. Supplier Change Notifications (SCNs) — Evaluate, document, and analyze supplier changes; coordinate cross-functional risk reviews. Supplier Qualifications — Conduct technical evaluations and process reviews for new and existing suppliers. Supplier Corrective Action Requests (SCARs) — Initiate, manage, and verify corrective actions; standardize closure timelines and root-cause quality. Non-Conformance Material Reports (NCMRs) — Lead NCMR investigations, trend analysis, and escalation for high-risk issues. Supplier Performance & Scorecards — Maintain scorecards and collaborate with suppliers on improvement plans. Approved Supplier List (ASL) Maintenance — Ensure accurate supplier status and requalification. Supplier Audits — Plan and execute on-site and remote audits; deliver detailed audit reports and risk assessments. Risk Assessments — Evaluate supplier risk and develop mitigation strategies. Continuous Improvement — Use engineering and statistical tools to optimize supplier processes. Product & Process Validation — Support first article inspections, capability studies, and technical evaluations. Regulatory Compliance — Ensure adherence to FDA, GMP, and other applicable standards. Cross-Functional Collaboration — Act as a liaison between Quality, Procurement, Engineering, and Regulatory teams. Required Qualifications Bachelor's degree in Engineering, Quality, or a related technical field. 7+ years in supplier quality, manufacturing engineering, or quality assurance. Experience with ISO 9001, supplier QMS audits, and process auditing. Strong root cause analysis and corrective action skills. Proficiency with risk assessments, quality audits, and eQMS/digital audit tools. Familiarity with FDA, GMP, and other regulatory standards. Excellent communication, negotiation, and interpersonal skills. Willingness to travel for supplier audits and evaluations. (Hybrid

• Waltham, MA) Salary
• 110•130k DOE KPG123