Associate Quality Systems Specialist at Medtronic

Seoul, Seoul, South Korea

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor’s degree in medical, biological science or equivalent field
Prior experience in a Quality Specialist role with 1 to 2 years of relevant experience, preferably in medical devices
Effective written and verbal communication skills in English and Korean
Strong ability to work well within a team and autonomously
Achievement oriented with ability to drive results with the highest quality standards
Excellent computer skills (knowledge of MS Office products)
High attention to detail and accuracy
Good prioritization and organizational skills
Excellent problem-solving skills

Responsibilities

Ensure that Medtronic Korea complies with Korea medical device regulation and ISO 13485
Maintain QMS procedures and quality records to align with global policies, local regulation, and local practice
Establish training matrix and assign training in learning management system
Conduct internal audit and corrective and preventive actions
Support external audit (e.g., MFDS’s random product inspection, unannounced surveillance inspection, foreign material event inspection, etc.)
Manage distributors and suppliers
Manage change control and risk management
Handle Product Complaint
Handle vigilance reporting (incl. overseas adverse event) and foreign material event reporting
Execute Field Corrective Action (FCA)
Implement Enterprise and regional projects for continuous improvement
Obtain KGMP certificate for overseas manufacturing sites

Skills

ISO 13485

QMS

CAPA

Internal Audit

MFDS

KGMP

Risk Management

Change Control

Vigilance Reporting

Field Corrective Action

Supplier Management

Training Management

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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