EXECUTIVE - QA [QMS (9001 / 13485)]

Hartalega NGC Sdn Bhd; Sepang; On-site; MYR 60,000 - 90,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Auditing

Data analysis

Quality system practices

Education

Bachelor's Degree in Science or Engineering

Job description

Coordinate with the Manager in developing, maintaining, and implementing an effective Quality Management System (QMS) in compliance with ISO 13485, ISO 9001, MDSAP, MDR, GDPMD, HALAL, BRC, HACCP, and other relevant standards. Support audits, inspections, and quality initiatives to ensure regulatory compliance and drive continual improvement.

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 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.

Qualification and Experience

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

Chemicals & Plastics Manufacturing 5,001-10,000 employees

The Hartalega story began in 1988. Our insatiable appetite to constantly surpass our own achievements has transformed what started as a single-line production facility into what we are today, the leading nitrile gloves manufacturer in the world, with a growing capacity to produce billions of gloves every year. We export to over 70 countries across five continents, namely Americas, Asia, Europe, Australia and Africa.

As an industry leader, we pave the way forward through our commitment to innovation. We invented the world's first lightweight nitrile glove, which revolutionalised the industry by shifting the global demand from latex to nitrile gloves. Today, we are home to advanced proprietary manufacturing technology that allows us to safeguard the quality of our products and the efficiency of our operations. Our unrivalled proprietary technology provides us with an important competitive edge as we own the fastest production lines in the industry, producing more than 45,000 gloves per hour.

In all that we do, we are guided by our SHIELD (Synergy, Honesty, Innovation, Excellence, Learning, Dedication) values to do the right thing at all times. As we continue to grow by leaps and bounds, we are single-minded in ensuring that we make a meaningful difference by enriching lives, from the healthcare practitioners and the people they care for to our very own #TeamHartanians, stakeholders and the community. We welcome like-minded individuals to be part of our exciting team. Together, let us make a difference.

The Hartalega story began in 1988. Our insatiable appetite to constantly surpass our own achievements has transformed what started as a single-line production facility into what we are today, the leading nitrile gloves manufacturer in the world, with a growing capacity to produce billions of gloves every year. We export to over 70 countries across five continents, namely Americas, Asia, Europe, Australia and Africa.

As an industry leader, we pave the way forward through our commitment to innovation. We invented the world's first lightweight nitrile glove, which revolutionalised the industry by shifting the global demand from latex to nitrile gloves. Today, we are home to advanced proprietary manufacturing technology that allows us to safeguard the quality of our products and the efficiency of our operations. Our unrivalled proprietary technology provides us with an important competitive edge as we own the fastest production lines in the industry, producing more than 45,000 gloves per hour.

In all that we do, we are guided by our SHIELD (Synergy, Honesty, Innovation, Excellence, Learning, Dedication) values to do the right thing at all times. As we continue to grow by leaps and bounds, we are single-minded in ensuring that we make a meaningful difference by enriching lives, from the healthcare practitioners and the people they care for to our very own #TeamHartanians, stakeholders and the community. We welcome like-minded individuals to be part of our exciting team. Together, let us make a difference.