Job Description:

• The Senior Supplier Quality Engineer will support External Manufacturing and Supplier Quality functions by executing both strategic and tactical quality activities.
• This includes base business support, nonconformance (NC) root cause investigations, and driving quality improvements to ensure compliance, reduce risk, and enhance efficiency.
• The role involves strong collaboration with suppliers and cross-functional teams (Procurement, Operations, R&D, Supply Chain, and NPI) to minimize supply chain risks while implementing innovative, measurable improvements.
• The ideal candidate will work with minimal supervision and bring deep knowledge of medical device regulations, GMP, and supplier quality systems.

Responsibilities:

• Provide sound, risk-based QA direction and make timely decisions on complex quality and compliance issues.
• Conduct root cause analysis and failure investigations; approve and monitor supplier corrective actions.
• Ensure execution of Quality Management Systems (QMS) related to supplier selection, change control, qualification, NC/CAPA, quality agreements, and performance monitoring.
• Lead risk assessment and mitigation strategies for suppliers, including Quality Agreement creation and control plan assessments.
• Serve as a key liaison with suppliers, ensuring strong relationships and compliance with regulatory and company requirements.
• Perform tasks in compliance with safety policies, quality systems, and cGMP requirements.
• Take on additional duties as assigned with flexibility and adaptability.
• External Manufacturing & Supplier Quality.
• Medical Device Regulatory Compliance (FDA, ISO 13485, 21 CFR Part 820).

Requirements:

• 4 6 years in a regulated medical device or life sciences manufacturing environment.
• Strong background in Supplier Quality Engineering.
• Hands-on production line experience including validation activities.
• Expertise in NC/CAPA, FMEA, Design Control, and New Product Introduction (NPI).
• Prior experience with Pharmaceutical or similar organizations is preferred.
• Critical thinking, detail-oriented, strong verbal and written communication skills.
• Demonstrated ability to lead projects within a regulated environment.
• Supervisory or team leadership experience; ability to drive timelines and project deliverables.
• Proficiency in Excel (chart creation, scheduling, tracking).
• Program or project management skillset.

• Provide sound, risk-based QA direction and make timely decisions on complex quality and compliance issues.
• Conduct root cause analysis and failure investigations; approve and monitor supplier corrective actions.
• Ensure execution of Quality Management Systems (QMS) related to supplier selection, change control, qualification, NC/CAPA, quality agreements, and performance monitoring.
• Lead risk assessment and mitigation strategies for suppliers, including Quality Agreement creation and control plan assessments.
• Serve as a key liaison with suppliers, ensuring strong relationships and compliance with regulatory and company requirements.
• Perform tasks in compliance with safety policies, quality systems, and cGMP requirements.
• Take on additional duties as assigned with flexibility and adaptability.
• External Manufacturing & Supplier Quality.
• Medical Device Regulatory Compliance (FDA, ISO 13485, 21 CFR Part 820)