Senior Quality System Specialist

## Senior Quality System Specialist Apply remote type:
Onsite locations:
Mystic, Connecticut, United States of America time type:
Full time posted on:
Posted Yesterday time left to apply:
End Date:
June 23, 2026 (4 days left to apply) job requisition :
R62662

We anticipate the application window for this opening will close on - 23 Jun 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
** Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results...the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier  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
** 5
* * 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.
* Provide 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.
* Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
* Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
* Lead audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
* Prepare reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
* Co-ordinate legal requests in support of government investigations or litigations.
* Ensure the quality assurance programs and policies are maintained and modified regularly.
* Facilitate uniform standards worldwide and enable best practice sharing, thereby fostering the achievement of company's mission globally.
** Must Have:

Minimum Requirements
*** To be considered for this role, please ensure the minimum requirements are evident in your applicant profile
** Requires a bachelor's degree with 4+ years of work experience in Quality or regulated industry OR Advanced degree with 2+ years of work experience in Quality or regulated industry
** Nice to Have
*** Working knowledge of SAP, Track Wise, 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…