QA Specialist (Contractor)

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:

Seoul, Korea, Republic of

Job Description:

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

[Job summary]

The positions responsibility oversights Quality & Compliance and Quality Systems execution in compliance with local regulatory requirements and J&J policies and standards. North Asia (HK, TW and KR) 

 

[Key Responsibilities]

1. Quality Management System (QMS) Compliance

• Ensure compliance of the Quality Management System against company Quality Policies and local regulatory requirements
• Develop and maintain local quality processes as required
• Monitor compliance and drive continuous improvement initiatives
• undefined

2. CAPA / Change Control / Audit Management

• Support and drive timely management of Non-conformance, CAPA, Change Controls, and Audit Actions
• Provide guidance for impact assessment and investigation
• Monitor trends and ensure timely completion of actions
• undefined

3. Quality Documentation & Audit Support

• Prepare and review quality documentation
• Gather and maintain required data and documents for audits and inspections
• Ensure audit readiness for both internal and external audits
• undefined

4. Complaint Handling & Safety Compliance

• Ensure complaints handling, adverse event reporting, and field actions are implemented in a timely and compliant manner
• Ensure alignment with applicable procedures and regulatory requirements
• undefined

5. Supplier Quality Management

• Ensure suppliers are qualified according to Purchasing Controls requirements
• Maintain supplier compliance with internal quality standards
• undefined

6. Training & QMS Support

• Support training plan administration and document management system
• Contribute to organizational quality capabilities through training processes

[Leadership Competencies]

• Quality & Compliance Mindset - Strong understanding of regulatory and quality requirements with the ability to ensure compliance and improve systems
• Analytical Thinking & Problem Solving - Ability to analyze trends in CAPA, complaints, and audits and drive data-based improvements
• Stakeholder Engagement - Effective communication and collaboration with cross-functional stakeholders to ensure timely execution of quality processes
• Ownership & Accountability - Self-motivated and able to work independently with minimal supervision while driving outcomes
• Continuous Improvement Orientation - Proactively identifies improvement opportunities in QMS and supports implementation of solutions

[Qualification]

Required

• 1 ~ 3 years of work experience in the healthcare industry or a similar regulated environment
• Understanding of Quality Management System and relevant regulatory requirements
• Strong communication, presentation, and interpersonal skills
• Proficiency in both spoken and written English
• Proficiency in standard business tools (e.g. Microsoft office)

Preferred

• Proficiency in standard business tools (e.g. Microsoft office)

[Job Type]

Fixed-term (12 months Contract)

 

 

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