Regional QA Associate Manager
7 days ago
Representing a prominent **Medical Device MNC **, this Company is seeking a **Regional QA Associate Manager **to join their team to manage their regional QA responsibilities.
This successful incumbent should be meticulous, detailed-oriented, and knowledgeable in quality assurance. They should also be articulate and comfortable with liaising with internal and external stakeholders.
This role will report to the Regional Director APAC & UK and functionally to the Company’s Medical Quality Director. The delegation is based on an alert level mandatory based on the stakes and on an active involvement in the quality decision.
**ROLES AND RESPONSIBILITIES**
- The position holder will be responsible for follow-up and maintenance of the Quality System processes, in compliance with respective Asia countries’ Quality System Regulations and/or ISO 13485. The incumbent will act as Management Representative for HCP reporting to the management for ensuring business activities are conducted in compliance with the regulations and applicable standards.
- Implements and maintains an adequate Quality System, in respect of ISO 13485, GMP, GDP, MDR, MDD 93/42 EEC or others
- Develop and improve the Quality Management at HCP
- Responsible of management review and Qualified Person for local market (Singapore).
- Maintains and improves Quality Management documentation.
- Ensures the correct implementation and maintenance of Quality Systems throughout the Company’s representative offices and affiliates, with continuous improvement in compliance with the local regulations
- Work closely with inter-departmental personnel to ensure quality is maintained throughout the organization
- Management of internal and external audits (by Global QA, certification bodies, health authorities etc.)
- Management of customer complaints - makes initial reporting to Headquarter, evaluate documentation for completeness and consistency, and assign additional actions as necessary and follow-up till closure.
- Ensure that all complaints requiring customer responses are properly addressed and in a timely manner
- Management of recall and withdrawal throughout Asia
- Management of materiovigilance (medical complaints, adverse events) throughout Asia either directly or via local QA personnel
- Management of deviations and corrective action plans where necessary
- Coordinate field safety notification and other post-market surveillance with the countries
- Manage the QA activities of distributors in Asia and ensure that their quality standards meet the Company’s Group’s standards (through audits, questionnaire assessments etc.)
- Manages the quality aspects in the development, sourcing, and supply of non-group products for Asia markets: Audits of the supplier and/or sub-contractor; Audit of the manufacturing facility, if necessary; Follow-up of the corrective action plans; Implementation and maintenance of the quality agreements and technical specifications.
- Support global and local initiatives and projects
- Reviews and approves Standard Operating Procedures
**REQUIREMENTS**
- Bachelor’s Degree in Science or Engineering or proven relevant experience
- 4-5 years of regional QA experience
- Strong interpersonal communication skills
- Ability to work cross-functionally and independently
- Excellent attention to detail and ability to deal with complexity
- Capable of effective time management
- Strong knowledge of quality standards and regulatory requirements (e.g. ISO 13485, GMP, GDP, MDR, MDD 93/42 EEC)
Principal Consultant: Cheong Yee Yin
Registration Number: R22108633
EA License Number: 17C8502
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