Senior Quality Systems Specialist jobs in United States
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Medtronic · 4 hours ago

Senior Quality Systems Specialist

Medtronic is a global healthcare technology leader committed to improving healthcare access and equity. The Senior Quality Systems Specialist will develop and maintain quality programs and systems to ensure compliance with regulations while collaborating with cross-functional teams to enhance quality and performance.

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

Responsibilities

Contributes to the development and maintenance of Quality programs, systems, processes, and procedures that ensure compliance with global policies, local regulations and practices
Supports monitoring and evaluation of process performance and quality to ensure conformance with internal and external standards
Provides guidance in interpreting policies, procedures, and external regulations to ensure compliance
Partners with cross-functional teams to identify and resolve compliance gaps and Quality issues
Supports audit and inspection preparation, execution, and resolution of findings
Supports Operating Unit and Enterprise change control processes
Supports the Field Corrective Action and Product Hold programs
Supports monitoring of key performance indicators and contributes to identifying improvement opportunities
Prepares QMS reports and provides necessary information to applicable internal and external stakeholders
Contributes to training and awareness initiatives that foster Quality culture and compliance

Qualification

ISO 13485ISO 14971Certified Quality AuditorData analysis toolsERP systemsAnalytical skillsContinuous improvementProblem-solving skillsCommunication skillsAttention to detail

Required

Requires a Baccalaureate degree
Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Preferred

Strong understanding of Quality and Regulatory system standards such as ISO 13485 and ISO 14971
Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or similar certification
Thinks creatively, embraces new approaches, and maintains strong attention to detail
Demonstrates curiosity and a drive for continuous improvement
Proficiency with data analysis and visualization tools (MS Excel, Power BI, etc.)
Strong analytical and problem-solving skills
Effective verbal and written communication skills
Experience with ERP systems (e.g. SAP)

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