Senior Quality Systems Specialist

Medtronic•Memphis, TN

3d•Onsite

About The Position

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 lives. The Senior Quality Specialist is responsible for leading and supporting Corrective and Preventive Action (CAPA) activities to ensure compliance with regulatory requirements and Medtronic quality standards. This role partners cross‑functionally with Manufacturing, Quality, Engineering, and other stakeholders to investigate quality issues, identify root causes, implement effective corrective and preventive actions, and verify long‑term effectiveness. This role will support training system effectiveness by ensuring training matrices are properly assigned to all job profiles, training documents are created, updated, and maintained. The role includes developing and maintaining work instructions, assisting management with training assignments, and supporting alignment of quality requirements. 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.

Requirements

Requires a bachelor’s degree and minimum of 4 years of work experience in quality or regulated industry OR advanced degree with a minimum of 2 years of work experience in quality or regulated industry

Nice To Haves

Experience supporting CAPA processes, QMS activities, and internal/external audits, including use of Agile MAP and TrackWise systems
Ability to develop, edit, and maintain work instructions and procedures while ensuring process compliance and timely documentation
Partner with technical experts to interpret complex information, communicate clearly to stakeholders, and support CAPA owners through investigation and closure
Coordinate audit backrooms, prepare and manage documentation, facilitate auditor interactions, and generate accurate QMS reports to support quality initiatives and continuous improvement
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.

Responsibilities

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 liaise with auditing groups and inspectors through all stages of the audits.
Prepare reports and/or necessary documentation (ex Corrective and Preventative Actions) and provide 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.
Collaborate openly and effectively with a range of stakeholders, process owners, and subject matter experts to define, maintain, and improve training programs to ensure the right training for the right audience without over-assignment.
Consult with training specialists and process owners on training strategy and effective adult learning methods.
Solid understanding of how laws, regulations, and standards influence training requirements.
Use creative problem solving to partner with learners, managers, and process owners to respond to, and resolve, issues.
Understand how laws, regulations, and standards influence training content.
Work independently to determine priorities and actions needed to manage workload.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
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)