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

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