[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:

Job Description

SCOPE OF THE ROLE AND BASIC PURPOSE

Key Responsibilities

In the EP/NV Quality assurance , Quality & Regulatory Compliance, based on compliance with laws and regulations and internal regulations (J & J Standard, etc.) and the quality management system, establish the system and manage and supervise the overall QMS system, including the management of NC/ CAPA, Internal Audit management, Quality system management review, Record management and audit response.

In addition, he/she shall accurately grasp the needs of customers and businesses, build a good, trusted relationship with each FC, 3 rd party, and stakeholders (including overseas), and establish more efficient QMS business processes.

Experience and Skills:

Required:



* Knowledge and practical experience of laws and QMS ministerial requirements



* Proactive approach/ Able to appropriately demonstrate unique initiatives



* Logical Thinking, Decision Making, and Problem-Solving Skills



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



* Excellent written and oral communication skills among government , 3 rd parties, organizations, and individuals.



* Business level English proficiency (Conversation, reading and writing)



* Project and Team Leadership



* Ability to multitask.

Preferred:



* At least 3 years of experience in quality system/ quality assurance/quality control and safety management.

(This is acceptable if you are in the pharmaceutical or medical device industry)



* Internal/External Audit Implementation and Response Experience (QMS Auditor License Holder )



* Experience in the cross-culture/global 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).

主要な責務

EP/NV Quality assurance Quality & Regulatory Compliance において、法規制や社内規定...