Quality Engineer

SmartSurgN; Selangor; On-site; MYR 50,000 - 70,000; Full time

Job summary

A medical device company in Selangor is seeking a Quality Engineer to ensure products and processes meet regulatory standards. The role involves maintaining the Quality Management System (QMS), performing inspections, and supporting supplier management. The ideal candidate will have a Bachelor’s degree in a relevant field and 2-3 years of experience in the medical device industry. Strong analytical and communication skills are essential for effective collaboration across teams.

Qualifications

• 2-3 years of experience in a quality, engineering or manufacturing environment, specifically in the medical device industry.
• Experience in supplier management and quality-related activities.
• Ability to work independently and effectively with cross-functional teams.

Responsibilities

• Implement, support and maintain the Quality Management System in compliance with ISO 13485 and 21 CFR Part 820.
• Perform inspections and prepare Device Master Records.
• Support and perform risk management activities.

Skills

Problem-solving

Analytical thinking

Organizational skills

Communication skills

Familiarity with statistical tools

Knowledge of FMEA

Knowledge of ISO 13485

Education

Bachelor’s degree in science, biomedical/electronic engineering or related disciplines

Tools

Microsoft Office

Job description

Overview

The Quality Engineer is responsible for ensuring that products, processes, and systems meet all applicable regulatory and quality requirements within the medical device industry. This role supports design, manufacturing, supplier quality, CAPA, and post‑market activities, and plays a key role in maintaining compliance with ISO 13485, FDA 21 CFR Part 820 and other applicable regulatory requirements.

Responsibilities

• Implement, support and maintain the Quality Management System (QMS) in accordance with ISO 13485, 21 CFR Part 820, and other applicable regulatory requirements.
• Perform incoming, in‑process and final release inspections.
• Prepare and maintain Device Master Records (DMR) / Device History Records (DHR).
• Establish, review, and update quality procedures, work instructions and records.
• Support internal & external audits.
• Update and support implementation of applicable changes according to the requirements.
• Handle and be responsible for CAPA, SCAR and nonconformities investigations and ensure timely closure of all activities.
• Support and/or perform risk management activities.
• Support supplier management activities including collaborating with suppliers on quality issues and continuous improvement initiatives.
• Perform any other duties as assigned.

Qualifications

• Minimum bachelor’s degree in science, biomedical/electronic engineering, or related disciplines.
• 2-3 years of experience in quality, engineering or manufacturing environment, particularly in medical device industry.
• Experience in supplier management and quality related activities.
• Familiarity with statistical tools and analytical technique.
• Knowledge of FMEA, ISO 14971 and root cause analysis methodologies.
• Knowledge of ISO 13485, 21 CFR part 820 and other applicable regulatory requirements.
• Proficient in Microsoft Office (Word, Excel, PowerPoint, MS Project).
• Strong organizational and documentation skills.
• Strong problem‑solving, analytical, and critical‑thinking abilities.
• Ability to work independently and effectively with cross‑functional teams.
• Ability to work in fast‑paced environments.
• Positive attitude and willingness to learn.
• Strong interpersonal, verbal, and written communication skills; able to interact effectively at all organizational levels.