Medtronic · 14 hours ago
Senior Quality Systems Specialist
Minneapolis, Minnesota, United States of America
Full-time
Hybrid
Mid, Senior Level
$90K/yr - $134K/yr
4+ years expMedtronic is a global healthcare technology leader dedicated to addressing challenging health problems. The Senior Quality Systems Specialist will coordinate the Quality CAPA Portfolio, ensuring compliance with internal policies and regulatory standards while providing guidance and support to CAPA Owners and Board Members.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
Responsibilities
Provide continuous and rigorous assessment of CAPA activities and documentation to assure compliance with Medtronic internal policies in general and specific to CAPA process, FDA regulations, ISO 13485, Medical Device Requirements, and governmental regulations through the review of CAPA records at critical phases
Participate in CAPA Board activity and perform CAPA Specialist role. Provide guidance, support and mentorship to CAPA Owners, CAPA Board Members and CAPA Board Chairs regarding the CAPA process, CAPA best practices, CAPA record content, and CAPA software tools
Track CAPA metrics and report on critical aspects regarding the health of the CAPA process
Support the development and implementation of Quality System CAPA procedures, CAPA software, and CAPA training programs
Support internal and external audits and inspections for CAPA records and processes. Participate in audits and inspections in multiple audit support roles in the front and back room
Provides 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
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to ensure compliance
Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations
Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits
Prepares reports and/or necessary documentation (e.g., Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external
Co-ordinates legal requests in support of government investigations or litigations
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
Qualification
Required
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
Preferred
Experience working with non-conformances, corrective and preventive actions (CAPA), including conducting effective root cause investigations, CAPA planning, execution, and verification of effectiveness techniques
Support and oversight of CAPA process, including management of high-visibility CAPA records
Ability to educate and influence others within the CAPA program; experience with CAPA documentation systems (e.g., Trackwise)
Experience in medical device, pharmaceutical, and/or other regulated environments
Strong analytical, process improvement, critical thinking, and decision-making skills
Project management skills and experience reviewing technical documentation
Strong written and verbal communication skills
Influence management skills; ability to work constructively across all functions of the organization and with external customers
Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and Medtronic quality requirements
Experience with internal and external audits
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)
Company
Medtronic
Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry.
10001+ employees
H1B Sponsorship
Medtronic has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (349)
2024 (387)
2023 (291)
2022 (310)
2021 (300)
2020 (261)
Funding
Current Stage
Public CompanyTotal Funding
$18.17BKey Investors
NHS EnglandBlackstone Life SciencesTrade Capital Funding
2025-09-15Post Ipo Debt· $1.76B
2024-05-29Post Ipo Debt· $3.24B
2023-03-23Post Ipo Debt· $2B
Leadership Team
Geoffrey Martha
CEO and Chairman Of The Board Of Directors
Linnea Burman
SVP & President, Neurovascular
Recent News
2026-02-07
Labiotech UG
2026-02-07
Company data provided by crunchbase