Head of Quality and Compliance

Hong Kong Permanent
  • 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.

Job Description

  • 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.

Zalika Ho
Quote job ref
Phone number
+852 3602 2400

Job summary

Life Sciences
Medical devices
What is your area of specialisation?
Healthcare / Pharmaceutical
Hong Kong
Job Type:
Consultant name
Zalika Ho
Consultant phone
+852 3602 2400
Job Reference