CAPA Quality Systems Specialist
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 As a CAPA Quality Systems Specialist , you will play a critical role in ensuring compliance with global regulatory requirements while helping to continuously improve our quality system to support innovation and patient safety. This is your opportunity to apply your quality systems expertise in a collaborative environment where your work truly matters.
Requirements
- Bachelor’s Degree and 2 years of relevant experience OR Advanced Degree and 0 years of relevant experience
Nice To Haves
- In-depth knowledge of FDA QSR, ISO 13485, and EU MDR.
- Strong problem-solving, critical thinking, and analytical skills.
- Excellent written and verbal communication skills.
- Experience working in a cross-functional, matrixed environment.
- ASQ certification (e.g., CQA, CQE, or CMQ/OE).
- Experience with Audit Management Systems (e.g., TrackWise, ETQ).
- Understanding of risk management (ISO 14971), software validation, or design control processes.
- Prior experience supporting multiple site operations or global quality systems.
Responsibilities
- Lead and support Quality System processes , such as CAPA (Corrective and Preventive Action), Internal Audits, Management Review, and Document Control.
- Serve as a subject matter expert (SME) for one or more Quality System elements in compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, and other global regulations.
- Facilitate and support internal and external audits (e.g., FDA, Notified Body, ISO) including audit readiness activities, evidence preparation, and post-audit follow-ups.
- Partner cross-functionally to evaluate, improve, and harmonize quality system processes and procedures.
- Analyze and interpret quality system data to identify trends and recommend opportunities for improvement.
- Support and mentor junior team members in the interpretation and application of quality system requirements.
- Participate in global projects and initiatives , helping to drive standardization and best practices across sites.
Benefits
- Medtronic offers a competitive Salary and flexible Benefits Package
- We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
- 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)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
