Sr. Global Supplier Quality Engineer

Senior Global Supplier Quality Engineer – External Manufacturing (Global)

Responsible for providing quality leadership and technical support to external manufacturing sites, ensuring robust quality systems and compliance with regulatory standards.

• Support the development and manufacturing of medical devices in conformance with Quality System Regulation, ISO
  13485, Medical Device Directive, ISO
  14971, IEC
  60601, and other regulatory standards.
• Investigate supplier‑related deviations, non‑conformances, and complaints.
• Issue and manage Supplier Corrective Action Requests (SCARs) and verify the effectiveness of corrective actions.
• Maintain quality relationships for change notifications, establish quality agreements, and strengthen relationships with Private Label Partners.
• Lead identification and resolution of quality issues and complaints, including facilitation of investigations and development of robust CAPA plans.
• Perform quality audits as required.
• Review and approve quality system documentation, including product disposition, manufacturing instructions, change controls, and process validation documentation.
• Monitor quality performance of ExM sites through the development of key performance indicators.
• Analyze data to identify risks and drive implementation of mitigation plans.
• Build relationships with internal and external partners and influence external manufacturers to continuously improve processes and procedures.
• Collaborate with external manufacturers during regulatory audits and inspections.
• Provide oversight during tech transfer and new product introduction activities.
• Guide interpretation of industry regulations within the framework of organizational products and sustaining development processes.
• Utilize coaching and facilitating skills with program shareholders to ensure proper project management, expectation setting, and best practices are utilized.
• Manage and develop a team of supplier quality engineers/analysts, providing coaching, performance management, and career development.
• Own supplier qualification, risk assessments, and onboarding activities, including quality agreements, approved supplier lists, and ongoing performance monitoring.
• Drive supplier audit programs (risk‑based audits, re‑audits, and for‑cause audits), including audit planning, execution, reporting, and follow‑up.
• Oversee supplier nonconformance management, deviations, and CAPA, ensuring timely root cause analysis, corrective actions, and effectiveness verification.
• Partner cross‑functionally with Procurement, Operations, R&D, Design Quality, and Regulatory to align supplier quality requirements with business and product needs.
• Establish and track supplier quality metrics (KPIs), conduct supplier business reviews, and present performance trends and risks to senior leadership.
• Lead continuous improvement initiatives to reduce supplier‑related defects, improve process capability, and strengthen supply chain resilience.
• Serve as escalation point for supplier quality issues, proactively assessing risk to product quality, compliance, and supply continuity.
• Support new product introductions and external manufacturing changes by ensuring supplier readiness, change control execution, and risk mitigation.
• Manage supplier quality oversight and compliance with FDA QSR, ISO
  13485, and J&J QMS requirements.
• Own supplier audits, CAPA, nonconformance investigations, and quality agreements.
• Partner cross‑functionally to mitigate supplier risk and support external manufacturing operations.

• B.S. in Engineering or associated scientific discipline.
• Minimum 5 years medical devices or pharmaceutical experience in quality or R&D engineering.
• DMAIC experience.
• Certified Quality Engineer (CQE) and Certified Quality Auditor (CQA).
• Proficient with Minitab.
• Coaching and mentoring skills.
• Proven ability to directly lead and/or co‑lead multiple tasks and projects.
• Strong understanding of industry expectations such as voice of customer, specification development, risk management, design verification and validation, stability studies, sterilization validation, biocompatibility, transportation testing, etc.
• Working knowledge of quality engineering…