- Leadership Role
- Competitive remuneration packages
About Our Client
Expanding & high potential medical device company with R&D and manufacturing facilities. Our client is looking for a very enthusiastic and self-driven high calibre to join the team.
- Develop, document and maintain the Quality system for compliance with ISO 13485 and others to achieve "always audit-ready" level of conformity.
- Actively champion and train teams to support the generation of records and evidence as a culture across the company
- Lead and conduct an on-site audit on critical suppliers and assess new potential suppliers
- Lead and manage customer inquiries, incidents investigation, complaint follow-up, and root cause analysis to ensure problems can be timely solved, low risk to stakeholders, and meeting both management & customer expectation.
- Lead continuous improvement by control of corrective actions and prevention
- Work with operating staffs to establish procedures, validations and specifications
- Responsible for QMS, GDP compliance and Quality System records
- Manage authorised activities and the accuracy and quality of records
- Prepare and review the initial and continuous training program for all personnel involved in distribution activities
- Review and monitor the use of suppliers and customers
- Handle customer complaints and assist in returned medicinal products
- Assist in creation and revision of any contract between the contract giver and the contract acceptor which specifies their respective responsibilities relating to wholesale distribution and/ or transportation of medicinal products
- Perform inspections and audits
- Ad-hoc tasks related to QA
The Successful Applicant
- Minimum of 6 years' experience in quality management field in which 4 years of them are in managerial experience and preferably in medical device
- Strong knowledge of ISO 13485 system
- Excellent quantitative, analytical and problem-solving skills
- Proficient in both written and spoken Chinese and English
What's on Offer
This company offers the successful candidates an attractive salary package with bonus and benefits.