Quality Systems Manager at Medtronic

Koto-ku, Tokyo, Japan

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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

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

Key technologies and capabilities for this role

ISO 13485QMS薬機法CAPAProduct RecallSafety AssuranceExternal AuditRegulatory ComplianceTeam ManagementProblem SolvingJapaneseEnglish

Questions & Answers

Common questions about this position

What compensation and benefits are offered for this role?

Medtronic offers a competitive salary and flexible benefits package. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

Is this a remote position or does it require office work?

This information is not specified in the job description.

What skills and experience are required for the Quality Systems Manager role?

Required skills include understanding of drug regulations, QMS ordinance, and ISO13485; 3-5 years of QA management experience in medical devices at a foreign company; experience with safety measures like recalls; people management and employee development experience; high communication skills in Japanese; adaptability, problem-solving, and sufficient English proficiency.

What is the company culture like at Medtronic?

Medtronic fosters a culture of exploration, innovation, and purpose-driven leadership to champion healthcare access and equity. The company values employee contributions, shares in their success, and unites a global team of over 95,000 passionate people focused on engineering extraordinary solutions.

What makes a strong candidate for this Quality Systems Manager position?

Strong candidates will have 3-5 years of medical device QA management experience in a foreign company, expertise in Japanese regulations like QMS ordinance and ISO13485, experience handling recalls and safety measures, proven people management skills, excellent Japanese communication, problem-solving abilities, and sufficient English to understand headquarters procedures.

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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