QA Engineer (Medical / ISO13485)

MINDe Group; Johor Bahru; On-site; MYR 150,000 - 200,000; Full time

Job summary

A leading global manufacturing company in Johor Bahru is seeking an experienced QA Engineer to ensure compliance with ISO 13485 and support daily production quality. The ideal candidate has at least 3 years of experience in quality assurance within regulated environments. The role offers a salary between RM4,500 and RM6,500, along with allowances and bonuses. The candidate must be proficient in quality tools and possess strong communication and documentation skills.

Benefits

Monthly allowance

Performance bonus

Medical and insurance benefits

Qualifications

• Minimum 3 years' experience in quality assurance, preferably in medical, electronics, or regulated manufacturing.
• Familiar with ISO 13485, ISO 9001, and QA documentation practices.
• Able to coordinate across departments and handle fast-paced QA activities.

Responsibilities

• Support in-line quality activities for daily production and assembly processes.
• Ensure compliance with ISO 13485, ISO 9001, and customer quality requirements.
• Liaise with engineering, production, and customer teams on quality issues.

Skills

ISO 13485

Quality tools (8D, CAPA, FMEA, SPC)

Strong communication skills

Documentation practices

Education

Diploma or Degree in Engineering, Quality, or related field

Job description

QA Engineer (Medical / ISO13485) – Johor Bahru – RM6,500 + Allowance + Bonus

A global manufacturing company is seeking a QA Engineer with experience in ISO 13485 or other regulated environments. This role supports daily production quality, audits, and customer quality requirements in a fast-paced, high-standard manufacturing environment.

What’s Offered

• RM4,500–RM6,500 basic salary

• Monthly allowance + performance bonus

• Medical, insurance, EPF, SOCSO

• Exposure to regulated manufacturing and global QA practices

• Career growth into compliance, audit, or customer QA roles

Core Responsibilities

• Support in-line quality activities for daily production and assembly processes

• Ensure compliance with ISO 13485, ISO 9001, and customer quality requirements

• Handle non-conformance investigations, root cause analysis, and CAPA execution

• Participate in internal and external audits, and assist with audit readiness

• Monitor quality data and trends to support process improvement initiatives

• Liaise with engineering, production, and customer teams on quality issues

• Maintain accurate documentation including inspection reports and corrective action logs

Requirements

• Diploma or Degree in Engineering, Quality, or related field

• Minimum 3 years' experience in quality assurance, preferably in medical, electronics, or regulated manufacturing

• Familiar with ISO 13485, ISO 9001, and QA documentation practices

• Experience with quality tools such as 8D, CAPA, FMEA, and SPC

• Able to coordinate across departments and handle fast-paced QA activities

• Strong communication and documentation skills

To Apply

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