Management System Auditor

CARE CERTIFICATION INTERNATIONAL (M) SDN BHD; Selangor; On-site; MYR 50,000 - 70,000; Full time

Job summary

A medical device certification company in Selangor is looking for a qualified individual with a degree in fields such as biomedical engineering or medical physics. The ideal candidate should have a minimum of four years of experience in the medical device industry, particularly in research and development or compliance testing. Additionally, preference will be given to candidates who have attended ISO courses and have MDA auditor qualifications. This role involves ensuring product standards and handling verification assessments.

Qualifications

• Completed a university or technical college degree or equivalent qualification in relevant fields.
• Minimum of four years full-time work experience in the medical device industry.
• Has attended ISO 13485 and ISO 9001 courses.

Skills

Reporting skills

Experience in product verification

Education

Bachelor's degree in Medical Physics or related field

Technical college degree in relevant fields

Job description

CARE CERTIFICATION INTERNATIONAL (M) SDN BHD – Selangor

Education Requirements

Completed a university or technical college degree or equivalent qualification in one or more of the following fields:

• Medical physics
• Biomedical engineering, biology or microbiology or biotechnology
• Chemistry or biochemistry
• Computer or software technology
• Electrical, mechanical or bioengineering
• Human physiology
• Medicine, dentistry, biomedical
• Pharmacy
• Physics or biophysics
• Other relevant fields

Experience

Minimum of four years full-time work experience in medical device related industry, especially:

• Research and development, manufacturing
• Health care services and with patients
• Testing devices for compliance with relevant national or international standards
• Conducting performance testing, evaluation studies or clinical trials of devices
• Substantial relevant experience in diagnostic, medical devices or pharmaceutical industries, health care professions, medical laboratories or test institutes

Requirements

• Has attended ISO 13485 and ISO 9001 course
• Priority will be given to candidate who has passed MDA examination and has obtained approval as MDA auditor
• Good reporting skill
• Experience in handling product verification and full conformity assessment