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. Role Overview 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 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 8C.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 8C.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. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$93,600.00 - $140,400.00 This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). Health, Dental and vision insurance Health Savings Account Healthcare Flexible Spending Account Life insurance Long‑term disability leave Dependent daycare spending account Tuition assistance/reimbursement Simple Steps (global well‑being program) Incentive plans 401(k) plan plus employer contribution and match Short‑term disability Paid time off Paid holidays Employee Stock Purchase Plan Employee Assistance Program Non‑qualified Retirement Plan Supplement (subject to IRS earning minimums) Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums) Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Equal Employment Opportunity It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life‑changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life‑long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career‑building resources you need. Life‑transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight‑driven care. Fresh viewpoints. Cutting‑edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E‑Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E‑Verify program, please click here. #J-18808-Ljbffr MED Medtronic Inc