Quality Management Lead – Medical Devices ISO Compliance

Hartalega NGC Sdn Bhd; Sepang; Vor Ort; MYR 60.000 - 90.000; Vollzeit

Zusammenfassung

Hartalega NGC Sdn Bhd is seeking a Quality Auditor to develop, maintain, and implement an effective Quality Management System (QMS) in line with ISO 13485, ISO 9001, MDSAP, MDR, and related standards. You will support audits, inspections, and continuous improvement initiatives to ensure regulatory compliance.

The role requires a Bachelor's degree in science or engineering and at least 1 year of auditing experience in a medical device setting; familiarity with ISO standards and quality systems is

Qualifikationen

• Bachelor's degree in science, engineering or related field.
• Minimum 1 year of auditing experience in a medical device manufacturing environment (fresh graduates may be considered).
• Strong knowledge of ISO 13485 and ISO 9001 standards.
• Skilled in auditing, data analysis, and quality system practices.

Aufgaben

• Drive implementation, monitoring, and continual improvement of the QMS in accordance 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, 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 cross-functional teams (QA, RND, Procurement, 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.

Kenntnisse

Auditing

Data analysis

Quality system practices

Ausbildung

Bachelor's Degree in Science or Engineering

Jobbeschreibung

Hartalega NGC Sdn Bhd is seeking a Quality Auditor to develop, maintain, and implement an effective Quality Management System (QMS) in line with ISO 13485, ISO 9001, MDSAP, MDR, and related standards. You will support audits, inspections, and continuous improvement initiatives to ensure regulatory compliance.

The role requires a Bachelor's degree in science or engineering and at least 1 year of auditing experience in a medical device setting; familiarity with ISO standards and quality systems is