Senior Quality Systems CAPA Specialist

Medtronic•Warsaw, IN

8d•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. As a CAPA Specialist at Medtronic’s Warsaw, IN manufacturing site, you will be integral to ensuring the quality and safety of our spinal implant and brain/ENT instrument components. You will lead investigations into product and process nonconformances, customer complaints, and audit findings specific to the design, manufacturing, and distribution of these critical medical devices. In collaboration with cross-functional teams, you will facilitate root cause analysis and drive the development of effective corrective and preventive actions to support both regulatory compliance and Medtronic’s mission of improving patient outcomes. You will be responsible for tracking, documenting, and managing CAPA records within the Quality Management System (QMS), ensuring all CAPA activities meet internal standards and FDA/ISO regulatory requirements. The CAPA Specialist will monitor the implementation and effectiveness of CAPA actions, prepare metrics and reports for management review and regulatory inspections, and act as a subject matter expert during internal and external audits. You will also identify and support continuous improvement opportunities in CAPA processes, and train site staff on CAPA procedures and best practices, helping to foster a culture of quality at Warsaw. Your work will have a direct impact on the reliability and safety of Medtronic’s spinal implants and brain/ENT instrument components, supporting our commitment to alleviating pain, restoring health, and extending life. This role is 100% onsite at our Warsaw, IN manufacturing site.

Requirements

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 Haves

Experience working with non‐conformances, corrective and preventive actions.
Experience conducting effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques.
Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques.
Support CAPA process and several individual records for a specific set of CAPAs that will have high visibility and require increased oversight.
Experience in medical device, pharmaceutical and/or a comparable regulated environment.

Responsibilities

Lead investigations for product and process nonconformances, complaints, and audit findings.
Facilitate root cause analysis and work with cross-functional teams to determine effective corrective and preventive actions.
Track, document, and manage CAPA records in the Quality Management System (QMS).
Monitor the implementation and effectiveness of CAPA actions.
Prepare CAPA metrics and reports for management review and regulatory inspections.
Participate in internal and external audits as a CAPA subject matter expert.
Identify and support continuous improvement opportunities in CAPA processes.
Train staff on CAPA procedures and best practices.

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)