Quality Systems Manager at Medtronic

Koto-ku, Tokyo, Japan

Apply Now

Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Understanding of drug and medical device laws (薬機法), QMS ministerial ordinance, and ISO13485
Medical device QA management experience in a foreign-affiliated company (3-5 years or more)
Experience with safety assurance measures such as product recalls
Personnel management skills and employee development experience
High communication skills (Japanese required due to large organization)
Resourcefulness, adaptability, and problem-solving abilities
English proficiency (sufficient to understand HQ procedures issued in English)

Responsibilities

Supervision of quality-related operations for CV (cardiovascular product group) related products based on QMS ministerial ordinance
Collaboration with quality operation leaders in other treatment areas (divided by treatment areas due to large organization)
Information sharing and operational collaboration with quality assurance personnel from other corporations (within the same group company, 2 corporations)
Shipment approval judgments for assigned product group
Confirmation and approval of product change management information
Confirmation and approval of protocols and documents for various safety assurance activities (recalls, modifications, information provision, etc.)
Confirmation and approval of various CAPA-related matters
Processing notifications from used product sales/lending vendors
Processing notifications from repair vendors
10.対応 to various external audits
Negotiations with regulatory authorities (as needed; typically handled by managers and specialists in each team)
Consideration of other quality-related escalated issues
Review of procedure creation and revisions
Participation in meetings with internal stakeholders (manufacturing, repair, regulatory affairs, etc.)

Skills

ISO 13485

QMS

薬機法

CAPA

Product Recall

Safety Assurance

External Audit

Regulatory Compliance

Team Management

Problem Solving

Japanese

English

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.

Land your dream remote job 3x faster with AI

Try Jobo Free