Sr Supplier Quality Engineer

We are seeking a Sr. Supplier Quality Engineer to support supplier quality activities for new product development and manufacturing within a regulated medical device environment. This role partners with cross-functional teams to ensure suppliers consistently deliver high-quality components, materials, and services while maintaining compliance with GMP, regulatory, and company quality standards. The ideal candidate will have experience in supplier quality, new product development (NPD), supplier qualification, audits, CAPA, and quality systems.

• Requires a Baccalaureate degree AND minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience
• Experience supporting new product development (NPD) or design transfer to suppliers.
• Strong analytical, collaboration, communication, and influencing skills, with the ability to lead cross-functional teams and drive quality decisions without direct authority.
• Partner with cross-functional teams to support supplier changes, nonconformances, and CAPA activities.
• Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
• Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.
• Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
• Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
• Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.