Senior Quality Systems Specialist at Medtronic

Jacksonville, Florida, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

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

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

Skills

Quality Management Systems

QMS

Regulatory Compliance

Audit Preparation

Change Control

Field Corrective Action

Product Hold

KPI Monitoring

Process Improvement

Cross-functional Collaboration

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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