Lead Specialist, Quality Assurance at Stryker

Tokyo, Japan

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, PharmaceuticalIndustries

Requirements

A background in science is preferred
Fluent English communication skills (including spoken and written, including emails)
Thorough knowledge of the Pharmaceutical and Medical Devices Act
Minimum 3 years of experience in quality assurance for medical devices
Experience in manufacturing environments, particularly in manufacturing management and quality assurance, is a plus
Experience with active medical devices is desirable
Ability to communicate effectively within an organization and with external stakeholders (pharmaceutical, quality assurance, quality control, sales, marketing, operations, repair, etc.)
Proactive problem-solving skills, with the ability to propose logical solutions to superiors
Honest and sincere approach, taking initiative and performing tasks diligently

Responsibilities

Compliance with the Pharmaceutical and Medical Devices Act and QMS guidelines
Processing quality information and customer support
Maintaining and ensuring compliance with ISO13485:2003 requirements
Proactively working to maintain and improve product quality for foreign manufacturers
Leading the implementation of product recalls and revisions (including internal coordination and communication with government agencies)
Pharmaceutical affairs (PMDA and local government correspondence)
Foreign manufacturer registration
Quality management system (QMS) compliance investigation
Maintaining and improving the QMS
Building and improving QMS compliance mechanisms, implementing improvement activities
Developing mechanisms to comply with new legal requirements (QMS)
Maximizing resource utilization (work-life balance) and promoting streamlined and efficient operations

Skills

Quality Assurance

ISO 13485

QMS

Medical Devices

Regulatory Compliance

PMDA

Product Recalls

Foreign Manufacturer Registration

Pharmaceutical and Medical Devices Act

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Medical & prescription plans

Supplemental health benefits

Flexible Spending accounts

Employee Assistance Program

Short-term & long-term disability

Tuition reimbursement

401(k) plan

Employee Stock Purchase Plan

Risks

Integration challenges from acquisitions may strain Stryker's resources.

Rapid tech advancements risk obsolescence of Stryker's current products.

Regulatory scrutiny on acquisitions could delay Stryker's market entry.

Differentiation

Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.

Entry into the peripheral vascular segment diversifies Stryker's market presence.

Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.

Upsides

Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.

The orthopedic implants market growth benefits Stryker's expanding product line.

Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.

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