Quality Systems Specialist jobs in United States
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Medtronic · 1 day ago

Quality Systems Specialist

Medtronic is a global leader in healthcare technology, dedicated to alleviating pain, restoring health, and extending life. As a Quality Systems Specialist, you will maintain and enhance the Quality Management System to ensure compliance with regulatory requirements and internal standards, supporting audit activities and quality initiatives.

Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
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H1B Sponsor Likelynote

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
Facilitate uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally

Qualification

Quality Management SystemRegulatory complianceAudit preparationCAPA documentationProcess analysisReport preparationCommunication skillsOrganizational skills

Required

Bachelor's degree with 2+ years of work experience in Quality or regulated industry OR Advanced degree with 0+ years of work experience in Quality or regulated industry

Preferred

Organize audit back rooms, prepare documentation, and facilitate communication between auditors and teams
Assist CAPA owners with documentation, ensure process compliance, and monitor timelines
Create and deliver accurate QMS reports to support quality initiatives and improvements

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

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Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry.

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 Company
Total Funding
$18.16B
Key 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

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Geoffrey Martha
CEO and Chairman Of The Board Of Directors
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Linnea Burman
SVP & President, Neurovascular
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Company data provided by crunchbase