Senior Quality Systems Specialist

Medtronic

Sr Quality Systems Specialist handling CAPA processes in healthcare technology. Ensuring compliance with regulations and providing guidance in quality assurance programs.

Posted 7/3/2026full-timeMounds View • Arizona, Florida, Massachusetts, Minnesota • 🇺🇸 United StatesSenior💰 $93,600 - $140,400 per yearWebsite

About the role

Key responsibilities & impact

Ensures the quality assurance programs and policies are maintained and modified regularly.
Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
Develops, modifies , applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product .
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment .
Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements .
Provides Corrective and Preventive CAPA oversite and guidance.
Develops employee communication and training programs that focus on the elements of a companywide CAPA and compliance program.

Requirements

What you’ll need

Requires a Bachelor's degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
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
Strong analytical, process improvement, critical thinking and decision-making skills
Ability to educate people in the CAPA program
CAPA documentation systems experience ( e.g. Trackwise , PQM )
Influence management skills; ability to work constructively across all functions of the organization as well as external customers
Project management skills
Experience reviewing technical documentation
Strong written and verbal communication skills
Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and Medtronic quality requirements
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.

Benefits

Comp & perks

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)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Standards DevelopmentProcess ImprovementAnalytical SkillsTechnical Documentation ReviewInspection And Testing Methods

Soft Skills

Influence ManagementStrong Communication SkillsCritical ThinkingDecision-MakingTraining And Education