品質保証・品質企画・安全管理部マネージャー at Abbott

Tokyo, Japan

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DiagnosticsIndustries

Requirements

4-year university degree or equivalent experience and knowledge (science-related major preferred)
At least 3 years of cumulative work experience in quality assurance department or comprehensive research institute, or equivalent experience
Academic and clinical knowledge of diagnostic drugs in general
Basic knowledge of immunoassays and blood tests
Ability to communicate with organizations inside and outside the company
English proficiency for business communication with overseas MPG (TOEIC: 600+)
Judgment: Ability to understand quality systems and make accurate judgments
Leadership: Ability to lead related department staff and own department's specialists/assistant specialists to advance work
Innovation: Ability to identify business problems without being bound by conventions and find improvement methods
Decision-making under difficulties: Ability to make timely decisions despite multiple obstacles, difficulties, or problems
Organization building and employee motivation: Ability to enhance members' motivation, skills, and experience for goal achievement
Communication skills: Ability to maintain smooth communication based on trust with internal company, government, industry, and partner companies
Completion of training specified in the education/training system procedure for quality system-related tasks

Responsibilities

Execute activities for maintaining and managing the quality system
Maintain product quality through product change management, CAPA, DMR maintenance, etc
Plan and implement customer interventions such as product recalls, repairs, and quality information provision
Maintain and manage complaint handling procedures, collect and report related quality information to promote product quality maintenance and improvement
Build, maintain, and improve the system for reliable and efficient support shipment judgment for i-STAT CLEW Update (software update)
Perform final product shipment approval judgments
Provide guidance and advice to specialists and assistant specialists in the responsible area
Conduct internal quality audits as an internal auditor at Matsudo plant and Mita headquarters
Monitor progress of quality assurance tasks and provide appropriate information to direct supervisor and relevant internal/external staff
Ensure quality assurance business processes conform to the quality system
Ensure progress of responsible tasks aligns with business goals
Promptly report issues in advancing responsible tasks to supervisor
Support twice-yearly APOC equipment i-STAT CLEW Update (software update), confirm progress of assigned specialists and assistant specialists, and provide necessary advice and adjustments
Perform other tasks instructed by supervisor

Skills

Key technologies and capabilities for this role

Quality Management SystemsCAPAChange ManagementProduct RecallComplaint HandlingInternal AuditingSoftware UpdatesShipment ApprovalEnglish CommunicationTOEIC

Questions & Answers

Common questions about this position

What is the base pay or salary range for this position?

The base pay for this position is N/A. In specific locations, the pay range may vary from the range posted.

Is this a remote position or does it require working at a specific location?

The position is located at Matsudo Plant in Japan, with additional locations not specified.

What education and experience are required for this role?

A 4-year university degree or equivalent experience and knowledge is required, preferably in a science field. Candidates need at least 3 years of cumulative experience in quality assurance or equivalent roles, along with academic and clinical knowledge of diagnostic drugs.

What key competencies are needed for this manager role?

Required competencies include judgment to accurately assess quality systems, leadership to direct team members and related departments, innovation to identify and improve business issues, decision-making under difficulties, team building and motivation, and strong communication skills.

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

Strong candidates have English proficiency (TOEIC 600+), ability to communicate with overseas MPG teams, and experience guiding specialists and assistant specialists while leading internal audits.

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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