Medtronic

Quality Affairs Specialist

Taipei City, Taipei City, Taiwan

Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, HealthcareIndustries

Requirements

Candidates should possess a Baccalaureate degree, typically obtained through advanced education, and demonstrate broad theoretical job knowledge. They should also have at least five years of experience in a quality affairs role, with a preference for experience within the medical device industry. Strong knowledge of quality systems, regulatory requirements, and internal policies is essential, as is the ability to interpret and apply relevant regulations.

Responsibilities

The Quality Affairs Specialist will provide oversight for the development and maintenance of quality programs and systems, ensuring compliance with policies and regulations. They will offer expertise in interpreting regulations, conduct process analyses, lead audit preparation and resolution, prepare reports, coordinate legal requests, and facilitate uniform standards worldwide. Additionally, the Specialist will work with operating entities to enforce requirements, deliver training, and advise management on risk mitigation strategies, ultimately contributing to the company’s mission globally.

Skills

Quality Systems
Regulatory Requirements
Internal Policies
Regulatory Interpretation
Process Analysis
Audit Preparation
Risk Mitigation
Training

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.

Key Metrics

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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