Executive QA: QMS & ISO Audits Specialist

Hartalega; Sepang; On-site; MYR 60,000 - 100,000; Full time

Job summary

Hartalega is seeking an Executive - QA to lead the development, maintenance, and implementation of a robust QMS in line with ISO 13485, ISO 9001, and related standards within a medical device manufacturing context.

The role involves coordinating audits, CAPA, SCAR, and document control, while driving continual improvement and ensuring regulatory compliance across cross-functional teams including QA, R&D, procurement and production.

Qualifications

• Bachelor’s degree in science, engineering or related field.
• Minimum 1 year of auditing experience in a medical device manufacturing environment.
• Strong knowledge of ISO 13485 and ISO 9001.
• Skilled in auditing, data analysis, and quality system practices.

Responsibilities

• Drive implementation, monitoring and continual improvement of the QMS in compliance with ISO 13485, ISO 9001, MDSAP, MDR and related standards.
• Conduct internal audits and assist in external, customer, and certification audits, ensuring timely closure of findings.
• Manage document and change control processes to maintain compliance, approval traceability, and version control.
• Administer and monitor CAPA and SCAR systems, including root cause analysis, follow-up, and reporting of effectiveness.
• Maintain quality documentation, records and KPIs, and prepare inputs for Management Reviews.
• Identify quality gaps and propose corrective and preventive actions to drive continuous improvement.
• Coordinate supplier quality programs, including supplier approval, qualification, audits, and SCAR management.
• Collaborate with QA, R&D, Procurement and Production on material qualifications and quality initiatives.
• Provide input on manpower, training, and performance needs, supporting staff readiness for audits and inspections.
• Build effective stakeholder relationships and contribute to training, knowledge sharing and departmental goals.

Skills

Auditing

Data analysis

Quality systems

Education

Bachelor’s Degree in Science/Engineering or related field

Job description

Hartalega is seeking an Executive - QA to lead the development, maintenance, and implementation of a robust QMS in line with ISO 13485, ISO 9001, and related standards within a medical device manufacturing context.

The role involves coordinating audits, CAPA, SCAR, and document control, while driving continual improvement and ensuring regulatory compliance across cross-functional teams including QA, R&D, procurement and production.