Assistant Quality Manager

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:

Shanghai, China

Job Description:

KEY ACCOUNTABILITIES

• Responsible for Chinese IFU/artwork approval as quality approver role. Responsible for National and Provincial Sampling, submitting relevant product documents and packing solution.
• Responsible for guide on incoming medical devices inspection at 3PL prior to their release to the Chinese market.
  Responsible for confirmation on disposition of non-qualified products.
• Oversight of 3PL daily operations.
• Support and supervise 3rd party to manage relabeling centre and distribution centre for incoming medical devices (direct sale business) prior to their release to the Chinese market.
• Lead audits of GxP suppliers and distributors, etc.
• Support coordination of internal and external audits (e.g. unannounced audits).
• Be responsible for field action or product recall internal coordination, support external communication and reporting to NMPA.
• Support inquiries on GxP compliance and internal quality control from NMPA, customers, etc.
• Closely cooperate with global functions, overseas manufacturing sites and local cross-functions to support local business needs.
• Identify current operation processes and lead improvement projects.

REQUIREMENTS

Education Requirement:
University graduate with background related to pharmacy, biotechnology, medical devices, medical, nursing, optics, optometry, optometry technology, etc.

Industry Experiences:
A minimum of 5 years in the medical device or pharmaceutical industry.

Position Experiences:
Experience in GSP. Manufacturing site experience preferred; GMP working experience, audit experience, and ISO 13485 knowledge preferred.

Language Skills:
English level at or above CET-6; skilled in oral and written English.

Computer Skills:
Familiar with MS software; knowledge of Excel for data analysis, PowerPoint for monthly presentations; SAP experience preferred.

Other Special Requirements:
Strong communication skills with different parties, independent problem-solving ability, self-driven, proactive in learning and managing change, etc.

 

 

Required Skills:

 

 

Preferred Skills:

Audit Management, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)