Senior Quality Systems Specialist

We anticipate the application window for this opening will close on - 9 Aug 2026   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 At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.  In this exciting role as a Sr Quality Systems Specialist you will have responsibility for the Quality and Compliance of process development and manufacturing for implantable Cardiac and Neuromodulation medical device related products at Medtronic’s Tempe Campus. Role includes providing a strong partnership with engineering and operations functions to support key Quality initiatives across campus in Tempe's Wafer & Sensor Operations (WSO) and Hybrid Manufacturing Operations areas. Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.                     Responsibilities may include the following and other duties may be assigned.   Provide oversight for the development, maintenance, and continuous improvement of quality programs, systems, processes, and procedures to ensure compliance with internal policies and external regulations/standards. Interpret and provide guidance on regulatory, governmental, and internal requirements; ensure quality processes and documentation meet governing standards. Partner with engineering, manufacturing, and other cross-functional teams to ensure quality standards are met across product realization, process development, and ongoing operations. Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished product, including supporting compliant internal quality procedures and systems. Lead and/or support audit and inspection readiness, execution support, and resolution of audit/inspection findings; liaise with auditors/inspectors through all stages of audits. Perform process analysis oversight to ensure requirements are enforced and sustained, including monitoring systemic trends, risks, and opportunities for improvement. Devises and implements inspection, testing, and evaluation methods for products and production equipment; designs/specifies testing mechanisms; conducts QA testing; and conducts analysis to assess and address nonconformance. Support manufacturing development and continuous improvement as the quality representative for process development and validation (including equipment development, IQ, process characterization, OQ/PQ, and test method development/validation). Applies use of acceptance criteria to support development of compliant test plans, protocols, and reports. Lead and/or support investigations and disposition of nonconforming product/materials/processes, including containment, population identification, documentation, and communication to applicable stakeholders. Drive CAPA activities, including investigation support, corrective action implementation, and effectiveness verification; ensure corrective measures meet reliability expectations and documentation requirements. Support and drive risk management (e.g., process FMEA) and change control, ensuring