Quality Engineer - Medical Devices & ISO 13485

Masimo; Pasir Gudang; On-site; MYR 80,000 - 100,000; Full time

Job summary

A medical device company in Johor, Malaysia is seeking a Quality Engineer responsible for ensuring product meets quality standards throughout manufacturing. The role encompasses supporting quality assurance processes, leading problem-solving initiatives related to manufacturing, and maintaining compliance with ISO 13485 and other regulations. Candidates should have 5-7 years of experience in device manufacturing, excellent communication skills, and be proficient in quality engineering tools. This position offers opportunities for professional growth in an innovative environment.

Qualifications

• Five to seven years of experience in quality engineering in a device manufacturing environment.
• Direct experience with ISO 13485 and quality system audits.
• Strong project management experience and ability to travel internationally.

Responsibilities

• Assist Quality Manager on the quality assurance and product quality.
• Supports product manufacturing using quality engineering tools.
• Leads problem-solving activities related to manufacture and inspection.

Skills

Root Cause Investigation

Problem Solving

Leadership skills

Project Management

Statistical Tools (Minitab, SQC)

Communication Skills

Education

B.S. in Science or Engineering

M.S. in Science or Engineering or MBA

Tools

Microsoft Office

Job description

A medical device company in Johor, Malaysia is seeking a Quality Engineer responsible for ensuring product meets quality standards throughout manufacturing. The role encompasses supporting quality assurance processes, leading problem-solving initiatives related to manufacturing, and maintaining compliance with ISO 13485 and other regulations. Candidates should have 5-7 years of experience in device manufacturing, excellent communication skills, and be proficient in quality engineering tools. This position offers opportunities for professional growth in an innovative environment.