ISO 13485 Quality Lead — Medical Device QC & Startup

E.U. Connector Sdn Bhd; Kulim; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading medical device manufacturer in Kulim, Malaysia, is seeking a Quality Supervisor/Engineer to oversee the ISO 13485 setup and ensure regulatory compliance during factory startup. Ideal candidates should have at least 3 years of experience in the medical device industry and be proficient in quality management systems. Strong QC skills and the ability to adapt to a fast-paced environment are required. Opportunities for training in China are available.

Qualifications

• Minimum 3 years of experience in the medical device industry.
• Proficient in ISO 13485 quality management systems.
• Experience in drafting quality system documentation.

Responsibilities

• Lead ISO 13485 setup and QC control.
• Conduct audits and ensure regulatory compliance during factory startup.
• Adapt to the fast-paced environment of initial factory setup.

Skills

ISO 13485 quality management systems

QC process control

Statistical analysis

Microbiology laboratory testing

Job description

A leading medical device manufacturer in Kulim, Malaysia, is seeking a Quality Supervisor/Engineer to oversee the ISO 13485 setup and ensure regulatory compliance during factory startup. Ideal candidates should have at least 3 years of experience in the medical device industry and be proficient in quality management systems. Strong QC skills and the ability to adapt to a fast-paced environment are required. Opportunities for training in China are available.