[Quality] Senior SpecialistAssociate Manager Quality System [Heart Recovery]

Tokyo - Japan

Monthly Salary: Not Disclosed

Posted on: 14 hours ago

Vacancies: 1 Vacancy

Job Summary

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

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

Required Experience:

Manager