Sr Quality Engineer.

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Education: Bachelor’s degree in engineering required. millions of people worldwide. The Sr. Quality Engineer supports quality assurance activities within a regulated manufacturing environment, ensuring products and processes meet applicable quality, regulatory, and business requirements. This role is responsible for supporting investigations, nonconformance management, CAPA, change control, validation deliverables, risk assessments, process monitoring, and audit readiness. The position partners cross-functionally with manufacturing, engineering, supplier quality, and operations teams to resolve quality issues, drive continuous improvement, and maintain compliance with FDA, ISO, GMP, and internal quality system expectations. The ideal candidate brings strong technical problem-solving skills, quality systems knowledge, manufacturing process experience, and the ability to produce clear, technically sound, audit-ready documentation.                     Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. Required Knowledge and Experience: Requires a Baccalaureate degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.

Bachelor’s degree in engineering required.

Minimum of 4 years of relevant engineering, quality, or manufacturing experience required; or a master’s degree in engineering with a minimum of 2 years of relevant experience OR PhD with 0 years relevant experience.

Bachelor’s or master’s degree in Mechanical, Industrial, or Electrical Engineering preferred. Experience in medical device or other FDA/ISO-regulated manufacturing environments, including GMP expectations and inspection readiness. Practical knowledge of ISO 13485, FDA Quality System Regulation expectations, nonconformance management, CAPA, document control, change control, and risk management. Knowledge of validation concepts for equipment, processes, products, and software, including URS, SRS, IQ, OQ, PQ, risk-based validation, and implementation readiness. Experience supporting NPI, product transfers, supplier qualification, supplier performance monitoring, component qualification, and supplier quality improvement initiatives. Manufacturing process knowledge in areas such as machining, anodizing, final packaging, inspection, test methods, component qualification, or other process