Senior Supplier Quality Engineer

The Senior Supplier Quality Engineer is responsible for managing and ensuring the quality and compliance of suppliers. The Senior Supplier Quality Engineer will conduct supplier audits, maintain the Approved Supplier List (ASL), monitor supplier performance through metrics, and oversee supplier-related quality activities to ensure that all products and materials meet regulatory requirements and internal quality standards. Must be able to demonstrate understanding of medical device regulations (ISO 13485, 21 CFR 820, etc.).

Accountabilities & Responsibilities
• Develop and maintain quality systems, processes, and procedures related to supplier quality management.
• Plan, schedule, and perform regular supplier audits to ensure compliance with company quality standards, regulatory requirements (e.g., ISO 13485, FDA), and contract specifications.
• Manage the supplier corrective action system by reviewing and prioritizing SCAR requests for completeness, coordinating SCAR tasks as appropriate, and compiling SCAR metrics for reporting.
• Track and analyze supplier performance using established metrics. Report on supplier performance to management, recommending corrective actions when necessary.
• Oversee and manage the ASL, ensuring that all suppliers are properly evaluated and qualified according to regulatory and company standards.
Review and approve new suppliers, re-qualify existing suppliers, and ensure the timely update of supplier records.
• Maintain accurate documentation related to supplier qualifications, audits, corrective actions, and performance metrics.
• Support the Supplier Management process in electronic Quality Management System by performing adminstrative tasks such as; coordinating supplier change evaluations, maintaining current supplier information, and recording results of metrics review.
• Ensure supplier evaluation and monitoring processes meet quality system requirements and company policies.
• Maintain and support administrative functions in quality management system software supplier modules as necessary.
• Other duties as assigned.

Education & Experience
Required:
• Bachelor’s Degree or an equivalent combination of education and work experience.
• 5+ years of experience in supplier quality management, supplier audits, or quality assurance, preferably within the medical device or regulated manufacturing industries.
• Experience with ISO 13485, FDA QSR, and other regulatory requirements for medical devices.
• Lead auditor certification through an accredited organization (e.g. ASQ, notified body, etc.).
• Ability to travel to supplier locations for audits and assessments (approximately 20% of the time) including internationally

Preferred:
• Proficiency with Netsuite or other ERP Software
• Experience with Grand Avenue Software
• CSQP or related certification
• Six Sigma belt certification

Knowledge & Skills
• Strong knowledge of supplier quality management processes and best practices.
• Proven ability to conduct supplier audits and assess supplier performance.
• Analytical mindset with strong problem-solving skills and attention to detail.
• Ability to work independently and collaborate effectively with cross-functional teams.
• Strong written and verbal communication skills, with the ability to influence and drive improvements.
• Knowledge of medical device regulations (21CFR820, ISO 13485).