Quality Assurance Engineer - Medical & Plastics

Masimo.; Pasir Gudang; On-site; MYR 56,000 - 100,000; Full time

Job summary

Masimo Malaysia is seeking an Assistant Engineer, Quality to support the Quality Department in maintaining product and process quality through inspections, audits, documentation, and improvement initiatives. You will assist in daily quality operations, participate in CAPA activities, and help prepare internal and external audits while ensuring compliance with ISO 9001, ISO 13485, GMP, and FDA requirements.

A Diploma or Degree in Engineering and 1–3 years in a quality role are required;

Qualifications

• Diploma/Degree in Engineering (Mechanical, Electrical, Biomedical, or equivalent).
• 1-3 years of experience in a quality-related role (fresh graduates with internship may be considered).
• Basic understanding of quality systems and standards (ISO 9001, ISO 13485, etc.).
• Familiarity with inspection techniques and measuring instruments (e.g., vernier caliper, micrometer, CMM).
• Knowledge of basic problem-solving tools (Fishbone, 5 Whys, Pareto, etc.).
• Good communication and documentation skills.
• Attention to detail and analytical thinking.
• Ability to work independently and in a team.
• Basic computer skills (MS Excel, Word, PowerPoint, ERP).
• Ability to operate a motor vehicle and maintain a valid Driver’s license.

Responsibilities

• Assist in daily quality operations including inspections, documentation review, and issue tracking.
• Support in monitoring in-process and final product quality to ensure compliance with internal and external specifications.
• Participate in root cause analysis and CAPA activities for non-conformances.
• Support incoming, in-process, and final inspections as required.
• Support the Quality Engineer in validation activities (IQ/OQ/PQ), test method validations, and equipment calibration.
• Assist in internal audits and external audits preparation.
• Maintain quality records such as inspection logs, NCRs, CAPAs, and etc.
• Help drive continuous improvement projects using quality tools such as 5 Why, Fishbone Diagram, and FMEA.
• Coordinate with cross-functional teams to resolve quality-related issues.
• Ensure compliance with ISO 9001 / ISO 13485 / GMP / FDA regulations.

Skills

Attention to detail

Analytical thinking

Communication skills

Documentation skills

Problem-solving

Education

Diploma/Degree in Engineering (Mechanical, Electrical, Biomedical, or equivalent)

Tools

Vernier caliper

Micrometer

CMM

ERP

MS Excel

MS Word

PowerPoint

Job description

Masimo Malaysia is seeking an Assistant Engineer, Quality to support the Quality Department in maintaining product and process quality through inspections, audits, documentation, and improvement initiatives. You will assist in daily quality operations, participate in CAPA activities, and help prepare internal and external audits while ensuring compliance with ISO 9001, ISO 13485, GMP, and FDA requirements.

A Diploma or Degree in Engineering and 1–3 years in a quality role are required;