[Quality] QA Specialist, Quality Systems [MedTech]

Posted 6 Days Ago
Be an Early Applicant
Hiring Remotely in Chiyoda, Ora, Gumma, JPN
Remote
Mid level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
The QA Specialist will maintain quality management systems, ensuring compliance with regulations, manage audits, and train employees.
Summary Generated by Built In

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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

▪ Maintain JJKK Quality Management Systems with highest level of compliance to Japanese regulations and J&J Quality Policies by analysing quality metrics, improving company procedures, train the employees and audit internal/external organizations. This role also needs to work together with other sectors (CON/Vision/JAN etc.), where needed, to maintain J&J Japan to be compliant with Japanese regulations.

▪ Maintain all business licenses which are required for JJKK business including but not limited to Marketing Authorization Holder (MAH) licences for Pharmaceuticals, Medical Devices.

▪ Address audits by internal (JJRC) and external auditing organizations (PMDA, TMG, TUV etc.)

▪ Responsible a couple of Quality Systems elements as “Process Owner”.

KEY RESPONSIBILITIES/TASKS

1. 90% - Establish the system and manage QMS system, including the management of NC/CAPA, Internal Audit management, Quality system management review, and audit response.

2. 10% - Audit Management

Required Competencies and Skills

▪ Excellent Communication skill in Japanese (interaction with auditors, government officials and internal stakeholders)

▪ Logical Thinking/Decision Making

▪ Good English Communication



Required Skills:



Preferred Skills:

Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing

Skills Required

  • Excellent Communication skill in Japanese
  • Good English Communication
  • Logical Thinking/Decision Making

Johnson & Johnson Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.

  • Healthcare Strength Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
  • Retirement Support Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
  • Parental & Family Support Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.

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The Company
HQ: New Brunswick, NJ
143,612 Employees
Year Founded: 1886

What We Do

Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines

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