Regulatory & Quality Assurance Engineer

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

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