QMS Engineer

INNIO GROUP SDN. BHD.; Ulu Tiram; On-site; MYR 60,000 - 90,000; Full time

Job summary

INNIO GROUP SDN. BHD. is seeking a Quality & Compliance professional to maintain QMS/EMS, support CAPA and internal audits, and drive continual improvement and regulatory compliance.

The role emphasizes documentation control, audit readiness, and collaboration with suppliers to ensure product safety and quality across ISO13485/ISO9001/ISO14001 frameworks. The ideal candidate has a diploma in a relevant field, 1–3 years’ experience, and strong analytical and communication skills in English and

Qualifications

• Diploma in Quality Management, Engineering, Environmental Science, Life Sciences, or related field.
• 1–3 years of QMS/EMS & CAPA experience in manufacturing or medical devices.
• Strong understanding of ISO13485, ISO9001, ISO14001.
• Knowledge of CAPA tools and root cause analysis methods (5 Why, Fishbone, 8D).
• Good documentation control and audit process knowledge.
• Proficient in MS Office; good English and Malay communication.

Responsibilities

• Maintain and control QMS/EMS documentation, ensuring compliance with ISO13485/ISO9001/ISO14001.
• Assist in planning, scheduling, and conducting internal audits; support external audits.
• Act as CAPA Coordinator: manage CAPA system, investigations, root cause analysis, and closure.
• Prepare data, reports, and minutes for Management Review; monitor QMS/EMS KPIs (NCs, CAPA, audit findings).
• Support supplier quality and environmental compliance (documentation, scorecards, corrective actions).
• Assist in training and awareness sessions on QMS, EMS, and GDP (Good Documentation Practice).
• Support continuous improvement projects, sustainability initiatives, and problem-solving activities.
• Participate in risk management and process validation activities where required.
• Ensure compliance with Health, Safety, and Environmental policies.

Skills

QMS

EMS

CAPA

Internal audits

Education

Diploma in Quality Management

Engineering/Environmental Science related diploma

Tools

CAPA software

Documentation control systems

Job description

Ensure that the Quality Management System (QMS) and Environmental Management System (EMS) are effectively implemented, maintained, and improved. Support Management Review, CAPA, internal audits, supplier quality, and compliance to ensure that the organization consistently meets regulatory requirements and customer expectations.

Key responsibilities

Maintain and control QMS/EMS documentation, ensuring compliance with ISO13485/ISO9001/ISO14001

Assist in planning, scheduling, and conducting internal audits; support external audits (customer, regulatory, certification body)

Act as CAPA Coordinator: manage CAPA system, ensure timely investigations, root cause analysis, and closure

Prepare data, reports, and minutes for Management Review; monitor QMS/EMS KPIs (NCs, CAPA, audit findings)

Support supplier quality and environmental compliance (documentation, scorecards, corrective actions)

Assist in training and awareness sessions on QMS, EMS, and GDP (Good Documentation Practice)

Support continuous improvement projects, sustainability initiatives, and problem-solving activities

Participate in risk management and process validation activities where required

Ensure compliance with company Health, Safety, and Environmental policies

About you

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

1–3 years of experience in QMS/EMS & CAPA (preferably in manufacturing or medical devices)

Strong understanding of Quality and Environmental Management Systems (ISO13485/ISO9001/ISO14001)

Knowledge of CAPA, root cause analysis, and problem-solving tools (5 Why, Fishbone, 8D)

Good documentation control and audit process knowledge

Analytical, planning, and prioritization skills

Good communication and interpersonal skills in English and Malay

Proficiency in MS Office (Word, Excel, PowerPoint)

Ability to work independently and take initiative

Awareness of regulatory standards such as ISO13485, ISO9001, ISO14001, and Medical Regulatory (i.e., FDA 21 CFR Part 820, EU MDA, Malaysia MDA, etc.) is a plus point