Senior Quality System Specialist

We anticipate the application window for this opening will close on - 8 Apr 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life In this exciting role as the Senior Quality Systems Specialist, you will use data analysis skills and CAPA experience to support the quality function completing audits at the Mystic, CT facility. 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 a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.​ Responsibilities may include the following and other duties may be assigned. Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external. Co-ordinates legal requests in support of government investigations or litigations. Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally. Required Knowledge and Experience: Requires a Baccalaureate degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience. Preferred Qualifications: Working knowledge of SAP, TrackWise, and Agile MAP systems. Solid understanding of CAPA processes, Quality Management Systems (QMS), and internal and external audit. Certified Quality Auditor (CQA) certification or project management(PMP) Experience with product release activities and nonconformance(NCMR) report. Proficiency in  quality data trending analysis, and quality data reporting. Demonstrated experience conducting root cause investigations, developing and executing corrective and preventive actions (CAPA), and effectiveness. Prior experience in a medical device, pharmaceutical, or similarly regulated industry 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- ... (truncated, view full listing at source)