QMS Engineer Principal

AGENSI PEKERJAAN MINDE GROUP SDN. BHD.; Johor; On-site; MYR 200,000 - 250,000; Full time

Job summary

A leading engineering solutions provider in Malaysia is hiring a QMS Engineer at Senior or Principal level to lead Quality Management System initiatives. The role includes maintaining audit readiness and driving compliance across manufacturing operations. The ideal candidate will have 10–12 years of experience in QMS roles and strong skills in CAPA and ISO 13485 standards. A competitive salary range of RM6,000–RM8,500 is offered, alongside additional bonuses and benefits.

Benefits

13th month/AWS

Performance bonus

Medical & insurance benefits

Qualifications

• Minimum 10–12 years of experience in quality assurance or QMS roles.
• Hands-on experience in QMS compliance, CAPA, MRB, and audit readiness.
• Leadership experience in regulated manufacturing environments is essential.

Responsibilities

• Design, implement, and maintain QMS processes aligned with ISO standards.
• Lead MRB and drive timely, risk-based decisions on nonconformities.
• Own the CAPA system and perform root cause analysis.

Skills

Quality Management Systems (QMS)

CAPA

ISO 13485

Audit readiness

Root Cause Analysis tools (8D, Fishbone, 5-Why)

Strong leadership

Education

Degree in Engineering (Electrical, Electronics, Mechanical, or Quality)

Tools

ERP systems (IFS, SAP)

Job description

A fast-growing international engineering solutions provider is hiring a QMS Engineer (Senior or Principal level) to lead and support Quality Management System (QMS) initiatives across manufacturing and engineering operations. This role is key to maintaining audit readiness, regulatory compliance, and continuous improvement across the business.

What’s Offered:

RM6,000–RM8,500 basic salary (based on experience & level)

13th month/AWS + Performance bonus + allowance + medical & insurance benefits

Exposure to medical and regulated quality standards (ISO 13485, FDA, etc.)

Strategic role in CAPA, MRB, and QMS leadership

Career growth into audit, compliance, or quality management roles

Core Responsibilities:

Design, implement, and maintain QMS processes aligned with ISO 9001, ISO 13485, FDA QSR, and related standards

Lead MRB (Material Review Board) and drive timely, risk-based decisions on nonconformities

Own the CAPA system: root cause analysis, effectiveness checks, and preventive action governance

Develop, review, and maintain quality procedures, work instructions, and controlled documents

Support incoming, in-process, and outgoing quality controls and inspections

Drive internal audits, management reviews, and system improvement projects

Collaborate with R&D and manufacturing teams during NPI to ensure quality planning

Coordinate field return investigations and corrective action follow-up

Support compliance efforts across ISO, IPC, cGMP, and regulatory standards

Mentor and coach QA team members and contribute to department capability building

Requirements:

Degree in Engineering (Electrical, Electronics, Mechanical, or Quality)

Minimum 10–12 years of experience in quality assurance or QMS roles

Hands‑on experience in QMS compliance, CAPA, MRB, and audit readiness

Strong knowledge of ISO 13485, ISO 900 FDA QSR, GMP, and IPC standards

Experience writing auditor‑ready procedures and managing document control

Skilled in RCA tools (8D, Fishbone, 5‑Why), SPC, FMEA, and risk management

Leadership experience in regulated manufacturing environments is essential

ERP systems experience (IFS, SAP) is an advantage

Six Sigma Black Belt certification is a plus

To Apply:

Submit your resume via JobStreet. Only shortlisted candidates will be contacted.

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