QMS & EMS Quality Engineer - CAPA & Compliance

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

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