Quality & Regulatory Affairs Engineers

Pentamaster Corporation Berhad; Penang; On-site; MYR 60,000 - 110,000; Full time

Job summary

PENTAMASTER CORPORATION BERHAD, a Malaysian investment holding company listed on Bursa Malaysia, seeks a quality/regulatory professional to establish and monitor the quality system in line with ISO13485:2016, US-FDA QSR and MDR. The role involves audits, document control, regulatory registrations and cross-functional collaboration.

You will coordinate internal/external audits, support product registrations, and lead CAPA/NC investigations while driving training and compliance initiatives across

Qualifications

• Associate Degree / Degree in any field.
• Excellent written and oral communication skills.
• Strong organizational skills.
• Hands-on knowledge of Word, Excel and PowerPoint.
• Teamwork in a cross-functional environment.
• Experience with GMP, ISO13485:2016 and related regulations is a bonus.
• Greenfield site development experience is an advantage.

Responsibilities

• Establish, monitor and maintain quality system implementations per ISO13485:2016, MDA Malaysia, US-FDA QSR, MDR and related regulations.
• Assist in monitoring and tracking company quality objectives.
• Manage quality document control system per ISO13485 and related regulations.
• Coordinate internal audits and process audits per ISO13485 and applicable standards.
• Coordinate preparations for external audits by certification bodies or customers.
• Manage product registration with regulatory bodies for current and new products.
• Provide regulatory affairs and technical support with marketing and development teams.
• Prepare training plans for cGMP and GDP for all employees and ensure compliance.
• Ensure corrective actions for audit discrepancies are closed effectively.
• Coordinate Change Control processes to implement changes and actions.
• Manage CAPA, NC investigations and related process activities.

Skills

Quality management

Regulatory affairs

Auditing

Documentation control

Cross-functional collaboration

Education

Associate Degree / Degree in any field

Tools

Word

Excel

PowerPoint

Job description

Establishing, monitoring and maintaining the quality system implementations in accordance with the ISO13485:2016, MDA Malaysia, US-FDA QSR, European MDR and related International Medical Device Regulations.

Key responsibilities

Assist in monitoring and tracking of company quality objectives

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

Co-ordinate internal audit and conduct process audit in accordance with ISO 13485 quality management systems, US-FDA QSR, European MDR and related International Medical Device Regulations

Coordinate for in-house preparation prior to external audit by certification body or customers

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, the design and development team on establishing the path of regulatory compliance for new 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

Ensure the corrective action replies of all internal and external audits discrepancies was closed effectively

Coordinate Change Control process (Document change, design change, production and process change) to ensure appropriate changes and actions are implemented

Manage Customer Complaint, Corrective Action and Preventive Action (CAPA) investigation as well as Nonconformances (NC) investigation and process activities

About you

Associate Degree / Degree in any field

Excellent written and oral communication skills

Strong organizational skills

Hands-on knowledge of computer applications including use of the Internet, Word and Excel applications and presentation software such as Power Point

Works well in a team-oriented, cross-functional environment

Experience working in a GMP, ISO13485:2016 and related International Medical Device Regulations is a bonus

Experience in the establishment and development of Greenfield sites is an advantage

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 http://www.pentamaster.com.my 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.

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 http://www.pentamaster.com.my 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.