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Job Function
Quality
Job Sub Function
Quality Assurance
Job Category
People Leader
All Job Posting Locations:
Chuo-ku, Tokyo, Japan
Job Description
SECTION 1: JOB SUMMAR
The Sr. Quality System Specialist represents the company as the person responsible for overseeing the quality management system. This role ensures compliance with Japanese regulations while adhering to company policies and requirements.
The Sr. Quality System Specialist is located at the Abiomed Japan Tokyo Office and reports to the Quality System Manager.
SECTION 2: DUTIES & RESPONSIBILITIES
In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- Manage documentation and records within the Quality Management System (QMS).
- Lead, maintain, and manage the implementation of QMS-related IT systems.
- Respond to internal quality system audits as well as external audits, including those conducted by health authorities and the US headquarters.
- Conduct internal and external audits, including supplier audits.
- Oversee QMS-related training activities.
- Responsible for communicating business related issues or opportunities to next management level
- Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
- For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed
SECTION 3: EXPERIENCE AND EDUCATION*
- A minimum of 3 years of experience in Quality Assurance or Quality System within the medical device industry or a related field.
- A minimum of 2 years of experience serving as an internal auditor, focusing on quality management systems.
- Strong knowledge of Japan PMD Act, QMS Ordinance and ISO13485: 2016 standards.
SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS
*
- Fundamental analytical and problem-solving skills.
- Basic proficiency in reading and writing English for business communication.
- Basic PC skills, including proficiency in Excel, Word, PowerPoint, and PDF software.
Required Skills
Preferred Skills:
Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboration, Detail-Oriented, Developing Others, Give Feedback, Goal Attainment, Human-Centered Design, Inclusive Leadership, Internal Controls, Leadership, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Risk Assessments
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