[Quality] QA Specialist, Commercial Quality [MedTech]

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 .

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.

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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

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