QMS Engineer

Innio Group Sdn Bhd; Kampung Baru Ulu Tiram; On-site; MYR 45,000 - 73,000; Full time

Job summary

Innio Group Sdn Bhd in Malaysia is seeking a quality professional to maintain QMS/EMS documentation and coordinate CAPA activities, audits, and compliance across ISO standards.

The role emphasizes managing investigations, reporting to Management Review, and driving continuous improvement in safety, quality, and environmental policies.

A Diploma in Quality Management or related field with 1–3 years' experience is preferred; strong English and Malay communication expected.

Qualifications

• Minimum Diploma in Quality Management, Engineering, Environmental Science, Life Sciences or related field.

Responsibilities

• Maintain and control QMS/EMS documentation in compliance with ISO 13485, ISO 9001 and ISO 14001.
• Plan, schedule and conduct internal audits and support customer, regulatory and certification audits.
• Act as CAPA Coordinator, managing investigations, root cause analysis, corrective actions and closure.
• Prepare reports, data and minutes for Management Review and monitor QMS/EMS KPIs.
• Support supplier quality, supplier scorecards and corrective actions.
• Conduct training and awareness sessions on QMS, EMS and Good Documentation Practice (GDP).
• Participate in continuous improvement, sustainability and problem-solving projects.
• Support risk management and process validation activities where required.
• Ensure compliance with company Health, Safety, Quality and Environmental policies.

Skills

QMS/EMS

CAPA

Internal audits

Document control

English & Malay communication

Education

Diploma in Quality Management or related field

Tools

MS Word

MS Excel

MS PowerPoint

Job description

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Maintain and control QMS/EMS documentation in compliance with ISO 13485, ISO 9001 and ISO 14001.

Plan, schedule and conduct internal audits and support customer, regulatory and certification audits.

Act as CAPA Coordinator, managing investigations, root cause analysis, corrective actions and closure.

Prepare reports, data and minutes for Management Review and monitor QMS/EMS KPIs.

Support supplier quality, supplier scorecards and corrective actions.

Conduct training and awareness sessions on QMS, EMS and Good Documentation Practice (GDP).

Participate in continuous improvement, sustainability and problem-solving projects.

Support risk management and process validation activities where required.

Ensure compliance with company Health, Safety, Quality and Environmental policies.

Key Responsibilities

• Maintain and control QMS/EMS documentation in compliance with ISO 13485, ISO 9001 and ISO 14001.

• Plan, schedule and conduct internal audits and support customer, regulatory and certification audits.

• Act as CAPA Coordinator, managing investigations, root cause analysis, corrective actions and closure.

• Prepare reports, data and minutes for Management Review and monitor QMS/EMS KPIs.

• Support supplier quality, supplier scorecards and corrective actions.

• Conduct training and awareness sessions on QMS, EMS and Good Documentation Practice (GDP).

• Participate in continuous improvement, sustainability and problem-solving projects.

• Support risk management and process validation activities where required.

• Ensure compliance with company Health, Safety, Quality and Environmental policies.

Requirements

• Minimum Diploma in Quality Management, Engineering, Environmental Science, Life Sciences or related field.

• 1–3 years of experience in QMS/EMS and CAPA.

• Experience in manufacturing or medical device industry is preferred.

• Strong knowledge of ISO 13485 / ISO 9001 / ISO 14001.

• Knowledge of CAPA, Root Cause Analysis, 5 Why, Fishbone and 8D.

• Good understanding of document control and audit processes.

• Knowledge of FDA 21 CFR Part 820, EU MDA or Malaysia MDA is an advantage.

• Experience in supplier quality and audit management is an added advantage.

• Good communication skills in English and Malay.

• Proficient in Microsoft Word, Excel and PowerPoint.

• Able to work independently, manage multiple priorities and work collaboratively.