Medical Device Process Engineer: Transfer, Validate & Scale

Epsilon Medical Devices; Selama; On-site; MYR 100,000 - 150,000; Full time

Job summary

A medical device manufacturer in Malaysia is seeking a professional to manage project process transfers and optimize production lines. The role involves compiling documentation for mass production and ensuring compliance with ISO 13485 and GMP regulations. Ideal candidates should have experience in establishing production operations and a strong ability to analyze and solve problems effectively. Knowledge of change control processes in the medical device industry is highly valued. Join us to enhance productivity through process improvements.

Qualifications

• Experience in establishing new production lines and operations.
• Experience participating in system audits.
• Familiar with GMP regulations and the change control process.

Responsibilities

• Lead the compilation and verification of Design Master Record documents.
• Verify production line equipment and develop validation protocols.
• Maintain and optimize mass production line processes.
• Assist R&D in resolving product design-related issues.
• Support the production team in achieving delivery targets.

Skills

Familiar with ISO 13485

Proficient in using office software

Strong problem analysis and resolution skills

Adaptability to new environments

Job description

A medical device manufacturer in Malaysia is seeking a professional to manage project process transfers and optimize production lines. The role involves compiling documentation for mass production and ensuring compliance with ISO 13485 and GMP regulations. Ideal candidates should have experience in establishing production operations and a strong ability to analyze and solve problems effectively. Knowledge of change control processes in the medical device industry is highly valued. Join us to enhance productivity through process improvements.