Senior Quality Systems Specialist

Medtronic • Memphis, TN

1d • 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. The Medtronic Mindset defines the expectations of our culture, emphasizing acting boldly, competing to win, moving with speed and decisiveness, fostering belonging, and delivering results the right way. 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 also support training system effectiveness by ensuring training matrices are properly assigned to all job profiles, and 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. Medtronic emphasizes in-person exchanges, requiring a minimum of 5 days a week onsite to foster professional growth and cross-functional collaboration.

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
• 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.

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

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

• 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)
• Paid sick time (for temporary employees, as required under applicable state law)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees