Senior QA Manager: Medical Devices & Regulatory Compliance

Sem Matic Sdn Bhd; Johor Bahru; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading medical device manufacturer in Johor Bahru is seeking a Quality Assurance Engineer to establish and maintain the Quality Management System in compliance with regulatory standards. Responsibilities include overseeing quality inspections, leading audits, and managing nonconformities. The ideal candidate will have a degree in Engineering and 3–5 years of experience in quality engineering, preferably in the medical device sector, along with strong knowledge of relevant quality tools and practices.

Qualifications

• 3–5 years experience in quality engineering, preferably in medical device manufacturing.
• Knowledge of ISO 13485, 21 CFR Part 820 (FDA QSR), and Good Manufacturing Practices (GMP).
• Familiar with Capability analysis reports.

Responsibilities

• Establish and maintain the Quality Management System (QMS).
• Oversee the approval of incoming materials, in-process production, and finished goods.
• Lead internal and external audits and manage documentation.

Skills

Quality tools (8D reports, Ishikawa diagram, PDCA)

Capability analysis

Measurement equipment usage (caliper, micrometer)

SPC software (Minitab)

CAPA report analysis/execution

Education

Degree in Engineering (Mechanical, Manufacturing, Biomedical or related field)

Tools

Quality Management software

Job description

A leading medical device manufacturer in Johor Bahru is seeking a Quality Assurance Engineer to establish and maintain the Quality Management System in compliance with regulatory standards. Responsibilities include overseeing quality inspections, leading audits, and managing nonconformities. The ideal candidate will have a degree in Engineering and 3–5 years of experience in quality engineering, preferably in the medical device sector, along with strong knowledge of relevant quality tools and practices.