Job Description

Salary Market Aligned

Location Penang FULL_TIME

Consultant Audrey Ng

Job Ref IXBRWG-C3B836D2

Date posted 28 July 2023 penang mining-engineering-operations/quality-assurance 2023-07-28 2023-09-26 medical-devices Penang MY Robert Walters https://www.robertwalters.com.my https://www.robertwalters.com.my/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png true

An exciting Quality Manager job has just become available at one of the leading medical device manufacturing company to be based in Penang. Reporting directly to the CQRO and dotted line to the COO, this is a role for a talent who is a leader in their field.

About the Quality Manager Role:
As the Quality Manager, you will be the management representative for company\'s Quality Management System (QMS) in Malaysia production sites, direct and functional reporting to CQRO and dotted line to the COO.

Key Responsibilities:

• Ensure processes needed for the QMS are documented, maintained and continually improved in compliance with applicable laws and regulations and consistent with policies, strategy and agreed quality and compliance objectives
• Monitor, measure and analyse processes, through internal audits, supplier audits, product quality reviews, KPIs and management reviews
• Implement an effective system for corrective and preventive actions (CAPA) to achieve planned results and opportunities for improvements
• Report to the \xe2\x80\x9cManagement at each Malaysian site\xe2\x80\x9d regarding the QMS performance and effectiveness to determine resource needs and escalate associated issues, risk and any need for improvements
• Lead and facilitate Malaysian Management\'s periodic review of the effectiveness, adequacy and suitability of QMS
• Appoint the individual(s) responsible to ensure regulatory compliance in specific subject matters required by those applicable laws and regulations, and applicable permits and regulatory authorisations

To succeed in this role, you will need to have extensive experience in quality management and regulatory affairs in the medical device industry. The candidate must be equipped with great interpersonal skills, customer-focused, self-motivated, willing to learn and adopt a collaborative and coaching approach.

Key Requirements:

• University degree in relevant applied sciences, e.g. chemistry, biology, pharmacy, medicine and/or engineering, or another internationally recognised equivalency
• At least 15 years of work experience including quality management, regulatory affairs, product development, clinical development, manufacturing, safety, occupational health, environmental protection and/or sustainability management related to medical devices or other life-science related products (e.g. pharmaceuticals)
• Experience leading quality control, quality assurance and regulatory compliance processes and associated activities related to medical devices or other life-science related products (e.g. pharmaceuticals) and their manufacturing process through all lifecycle phases of a product and with collaboration with external organisations. That includes having knowledge and experience with ISO 13485 and MDR/MDD
• Experience in risk management/quality risk management of products, and their manufacturing process, internal work processes, outsourced activities and procured materials and services and their associated suppliers
• Experience in internal auditing and inspection of external partners and suppliers of outsourced activities and procured materials and services
• Experience leading preparation of, participation in, responding to observations and/or hosting authority inspections or audits by notified bodies and customers

This firm needs no introduction and is recognised as the leader in their field of expertise. The culture is demanding but if you are confident and have a can-do attitude the potential rewards are significant.

If you are a talented and focused Quality Manager seeking the right opportunity to take your career forward, this job is the role for you. You will be a part of forward-thinking company that values innovation and a progressive mindset.

If you would like to apply for this role or find out more, please email me at

Robert Walters