Senior Quality Systems Specialist

Job description

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 LifeAt 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 thorough assessments and compliant implementation strategies and documentation; develop/maintain quality metrics and reporting (scorecards, issue reporting, performance measures) to guide action and decision-making. Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience. Nice to Have: Experience with electronics manufacturing including wafer fabs and microelectronics assembly (SMT and/or chip and wire). Strong background in Equipment Development, IQ, Process Characterization, OQPQ, and Test Method Development and Validation. Six Sigma or Lean Sigma belt certification DRM or DFSS certification Experience with internal and external audits including FDA, MDSAP and/or TUV. 4+ years of experience in a healthcare or medical device manufacturing environment Strong understanding of medical device manufacturing processes and products Experience with general quality principles, procedures and methodologies Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.) Strong statistical analysis techniques & DOE design and execution Strong overall communication, both in technical writing and presentation skills, as well as experience with presentation tools and applications 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. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. ‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. 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