Senior Supplier Quality Engineer

Job Description

A leading medical device company is seeking an experienced Supplier Quality Engineer to ensure supplier compliance, drive continuous improvement, and support manufacturing excellence. The ideal candidate will have a strong background in supplier controls, problem-solving methodologies, and quality systems within a regulated environment.

Top 3 Required Skills

1. Strong background in Quality Systems related to Supplier Controls
2. Proven excellence in Problem Solving (DMAIC, CAPA, or similar)
3. Experience with SAP, Agile, and TrackWise (nice to have)

Education & Experience

• Bachelor’s degree with 4+ years of relevant experience OR
• Advanced degree with a minimum of 2 years relevant experience

Key Responsibilities

• Ensure suppliers deliver high-quality parts, materials, and services in compliance with company and regulatory standards.
• Lead cross-functional teams to investigate and resolve supplier-related quality or compliance issues identified during incoming inspections.
• Drive and/or support CAPA and preventive action efforts for supplier-related issues, audit findings, and complaint investigations.
• Coach and mentor team members on supplier quality principles, quality systems, and statistical analysis.
• Define and execute component qualification strategies (e.g., PPAP), and partner with suppliers to establish qualification and control plans.
• Qualify suppliers according to internal standards and maintain Certified Supplier Programs to ensure cost-effective processes.
• Monitor parts through the full manufacturing cycle, addressing supplier performance issues proactively.
• Evaluate and assess supplier performance, providing actionable feedback and driving continuous improvement.
• Deliver Product Acceptance Sampling Strategies, manage the Approved Supplier List, and define Receiving Inspection and test method validation requirements.
• Lead supplier change request evaluations and approvals.
• Support internal and external audits, including preparation, participation, and resolution of findings.
• Collaborate cross-functionally with engineering, manufacturing, and quality teams to ensure timely closure of supplier CAPA records.

Preferred Experience & Knowledge

• Advanced Supplier Development: auditing, process improvement, cost reduction, SPC, Quality Plans, Control Plans, and FMEAs.
• CAPA/SCAPA: strong investigation and root cause analysis skills.
• DMAIC and other structured problem-solving tools.
• Working knowledge of ISO 13485 and other medical device industry standards.
• Experience in medical device manufacturing environments.
• Proficiency in Minitab or equivalent statistical tools.