[Quality] QA Specialist, Commercial Quality [MedTech]

Posted 7 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 is responsible for quality assurance methods, supplier management, customer complaint handling, and ensuring compliance with Japanese regulations in product quality.
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:

SCOPE OF THE ROLE AND BASIC PURPOSE

▪ Responsible for establishing methods of quality assurance, providing these methods to relevant departments, and maintaining them so that intended products are consistently delivered to customers.

▪ Responds to information on product defects and customer complaints, contributing to both productivity and customer satisfaction, as well as to product quality improvement.

KEY RESPONSIBILITIES/TASKS

Supplier Management

▪ Guide and supervise overseas manufacturing sites to ensure they meet Japanese legal requirements (e.g., site certification or registration activities, QMS compliance of overseas facilities).

▪ Manage and guide other companies involved in J&J marketed products.

▪ Monitor, manage, and provide improvement guidance for deliverables from suppliers involved in QA-managed processes.

General QMS

▪ Ensure competency and provide training to internal and external stakeholders involved in QA-managed processes.

New Product Introduction (Design Control)

▪ Understand design control, mass-production transfer, and manufacturing/quality control processes, and establish methods for ensuring product quality throughout each process.

▪ Confirm compliance when new or revised technical standards applicable to products are issued.

Order Receipt & Shipment

▪ Build systems related to product shipment to the market, approve shipment acceptance or rejection in the event of deviations or non-conformities, and issue instructions for shipment holds/releases.

Manufacturing and Service

▪ Manage the execution status of quality operations in domestic final storage.

▪ Guide and supervise overseas manufacturing sites to ensure they meet Japanese legal requirements (e.g., site certification or registration activities, QMS compliance of overseas facilities).

Repair, Installation, and Ancillary Services

1. Review & Approve documents related to product quality (documents: specifications, procedures, rules, records).

Customer Complaint Management

▪ Manage customer feedback (including complaints) processes and perform complaint-handling operations.

Product Inspection & Product Improvement

▪ Review & Approve documents related to product quality (documents: specifications, procedures, rules, records).

▪ Promote corrective and preventive actions related to product quality issues and provide input to the Franchise for product improvement.

System Improvement Management / CAPA

▪ Manage recall processes and carry out recall activities (regulatory communication, progress management, confirmation of recalled items).

▪ Act as an SME (Subject Matter Expert) during audits in the capacity of product Quality representative)

ACCOUNTABILITIES/KEY MEASURES

▪ Complaints Management- On time analysis and customer feedback

▪ QMS & FMR- Timely completion for both of NPI & LCM projects

▪ Quality Actions such as Stop Shipment, Field Actions- Timely actions/completion

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
  • Knowledge of Quality Management Systems (QMS)
  • Experience in Compliance Management

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.

Johnson & Johnson Insights

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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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