Quality & Regulatory Affair Section Head

Quality & Regulatory Affair Section Head

Establishing, monitoring and maintaining the quality system implementations in accordance with the ISO 13485 : 2016, MDA Malaysia, US-FDA QSR, European MDR and related International Medical Device Regulations.

Main Responsibilities

• Responsible to assist in monitoring and tracking of company quality objectives.
• Responsible to manage quality document control system in accordance with the ISO 13485 : 2016 quality management system, US-FDA QSR, European MDR and related International Medical Device Regulations.
• Responsible to co-ordinate internal audit and conduct process audit in accordance with ISO 13485 quality management system, US-FDA QSR, EU European MDR and related International Medical Device Regulations.
• Responsible to coordinate for in-house preparation prior to external audit by certification body or customers.
• Responsible to manage the entire process of product registration of current and new products with various regulatory bodies.
• Provide regulatory affairs and technical support by working together with marketing, e Research and development, Engineering team on establishing the path of regulatory compliance for new / existing products.
• Prepare training plan for cGMP and GDP training of all employees of the company as well as supervision of the compliance of the standards.
• Responsible to ensure the corrective action replies of all internal and external audits discrepancies was closed effectively.
• Coordinates Change Control process (Document change, design change, production and process change) to ensure appropriate changes and actions are implemented.
• Responsible for the management of Customer Complaint, Corrective Action and Preventive Action (CAPA) investigation as well as Nonconformances (NC) investigation and process activities.
• Maintain Risk Management File and coordinate Risk Analysis with other functions & ensure Risk Analysis has been developed, evaluated and reviewed.
• Corresponded with regulatory authorities regarding planning of registrations, time frames and in case of enquiries.
• Perform any other pertinent responsibility that may be assigned occasionally as required by Top Management or immediate superior.

Application Questions

Manufacturing, Transport & Logistics 101-1,000 employees

PENTAMASTER CORPORATION BERHAD, a Malaysian investment holding company listed on the Main Board of Bursa Malaysia Securities Berhad, is one of the global leaders in providing advanced, world-class manufacturing automation solutions & services to help worldwide customers meet their productivity challenges & maintain the edge required for success in a competitive business environment.

Through our subsidiaries, we provide an integrated range of innovative services in technological solutions, manufacturing of automated & semi-automated machinery & equipments, designing & manufacturing of precision machinery components, as well as design, assembly & installation of computerized automation systems & equipments.

With more than 25 years of experience in dealing with high-end technology companies across worldwide markets, we are confident to compete in terms of manufacturing flexibility, quality services, cost-effective solutions, timely delivery & positioned for greater growth.

History

Check our website under 'Milestones'

Product & Services

Standard Semiconductor Back-end Equipment. Customized Automated Solutions. Vision Inspection System. Material Handling Solutions. Test and Measurement System. High Precision Components Manufacturing. Equipment Contract Manufacturing. Shopfloor Management System. RFID Application Solutions. Logistics and Warehouse Solutions.

Vision

To provide world class automation solutions to the Manufacturing Industries in the Global Market

Mission

We are dedicated in delivering high quality and cost effective products with value-added services. In our effort to meet our mission, we strive to provide benefits and satisfaction to our customers, vendors, employees and the community as a whole.

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