Assistant Quality Manager
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Job Location:
Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
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.
Job Function:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
ProfessionalAll Job Posting Locations:
Shanghai ChinaJob 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)Required Experience:
Manager
Key Skills
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
