Supplier Quality Engineer II

Medtronic is a global leader in healthcare technology with a mission to alleviate pain, restore health, and extend life. The Supplier Quality Engineer II will be responsible for ensuring suppliers deliver quality parts and services, qualifying suppliers, and providing technical guidance throughout the New Product Development lifecycle.

Responsibilities:

• 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
• Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: 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

Requirements:

• Requires a Baccalaureate degree and minimum of 2 years of relevant quality experience OR Master's degree with a minimum of 0 years relevant experience
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
• Prior knowledge with ISO13485 standards
• Experience negotiating and finalizing Quality Agreements with external suppliers
• Strong knowledge of supplier quality requirements and applicable regulations
• Ability to interpret quality system requirements and translate them into contractual obligations
• Excellent written and verbal communication skills
• Proven cross-functional collaboration with sourcing, legal, regulatory, and operations teams
• Strong risk assessment, issue resolution, and decision-making capabilities
• High attention to detail in document review, redlining, and approval workflows