[Quality] QA Specialist, Quality Systems [MedTech]

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through 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 humanity.Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Quality

Job Sub Function:
Customer/Commercial Quality

Job Category:
Professional

All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description:

Quality & Regulatory Compliance in Johnson and Johnson K.K.

is recruiting for Surgery QRC Staff, located in Tokyo HQ office.

Key Responsibilities

Ensure compliance with applicable domestic and international regulations, standards, and quality requirements.

Develop and maintain an effective Quality Management System (QMS) that addresses the needs of internal stakeholders, and execute quality system activities in accordance with established procedures, including document control, change management, and business license management.

In addition, develop and implement initiatives that deliver value to both internal stakeholders and customers through the QMS.

Proactively identify and understand customer needs, business requirements, and organizational changes, while building strong and trusted relationships with stakeholders, including global partners, to establish simpler, more efficient, and reliable QMS processes.

Experience and Skills:

Required:


* Knowledge and practical experience of laws and QMS ministerial requirements


* Proactive approach/ Able to appropriately demonstrate unique initiatives


* Ability to work both independently and in collaboration with others.


* Proactive approach/uses own initiative appropriately.


* Logical thinking, decision making, problem-solving skills, positive thinking, and attitude to learn new things.


* Has a strong commitment to achieving goals and a flexible ability to execute.


* Native verbal and written communication skills in Japanese.

Preferred:


* At least 3 years of experience in Quality Assurance or Quality System function within the regulated Medical Device or Pharmaceutical industry


* English skill in business level.


* Experience in global/cross culture environment.


* IT/Digital literacy

Education:

• Bachelor's degree or educational equivalent (Health science or other directly related field or equivalent combination of education is preferred).

Johnson and Johnson K.K.のMed...