Senior Supplier Quality Engineer

Medtronic is a global leader in healthcare technology, committed to innovation and improving healthcare access. In this role, the Senior Supplier Quality Engineer will oversee the quality management of suppliers, ensuring compliance with industry standards and addressing quality issues in collaboration with internal teams and external partners.

Responsibilities:

• Ensure that suppliers deliver quality parts, materials, and services
• Qualify suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness
• Monitor parts from acquisition through the manufacturing cycle and communicate and resolve supplier-related problems as they occur
• Evaluate suppliers' internal functions to assess their overall performance and provide 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
• Provide 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
• Collaborate 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
• Develop and prioritize 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

Requirements:

• Bachelor's Degree in Engineering, Science or technical field with 4 years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2 years of work experience in Engineering and/or Quality OR PhD with 0 years relevant experience
• Experience supporting supplier change management in the medical device industry, including familiarity with Medtronic Supplier Change Request (SCR) processes and regulated change management systems
• Strong knowledge of regulatory and quality requirements including FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and ISO 14971 risk management principles
• Experience working with OEM suppliers, contract manufacturers, and sub-tier suppliers in regulated environments, including supplier risk assessments, supplier audits, supplier performance monitoring, and supplier development
• Demonstrated experience evaluating design changes, manufacturing transfers, process validations, and supplier-driven process changes
• Expertise in validation and process qualification activities including IQ, OQ, PQ, and TMV, with working knowledge of manufacturing assembly processes and inspection/testing methods
• Working knowledge of statistical and quality engineering tools including Design of Experiments (DOE), Measurement System Analysis (MSA), Process Capability, and Statistical Process Control (SPC)
• Experience with quality system processes including nonconformance management, UAI dispositions, failure investigations, and nonconforming product controls
• Knowledge of continuous improvement methodologies including First Time Quality (FTQ), Lean, and Six Sigma principles
• Proven project management experience with the ability to manage multiple supplier change requests simultaneously in fast-paced environments
• Strong cross-functional collaboration with Quality, Regulatory, Operations, and R&D teams, along with effective stakeholder management when working with global teams and external suppliers
• Excellent organizational, planning, technical writing, communication, and presentation skills, with the ability to work effectively in team and partnership environments