Process Engineer

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

1. Responsible for new project process transfer, leading the compilation and verification of Design Master Record (DMR) documents required for mass production, including technical documents such as process flow charts and standard operating instructions;
2. Responsible for the verification of production line equipment and manufacturing processes, developing and executing validation protocols to ensure that production conditions meet quality and technical requirements;
3. Responsible for the maintenance and optimization of mass production line processes, promptly addressing process issues during production, and assisting in improving production line efficiency and product quality;
4. Assist the R&D department in analyzing and resolving product design‑related issues, and provide manufacturability improvement suggestions;
5. Support the production team in achieving delivery targets by driving capacity enhancement and cost optimization through process improvements and technological innovations.

What we're looking for

1. Familiar with ISO 13485 and GMP regulations;
2. Proficient in using office software;
3. Experience in establishing new production lines and production operations;
4. Experience participating in system audits;
5. Familiar with the change control process in the medical device industry;
6. Proactive, resilient under pressure, keen at identifying potential issues, with strong problem analysis and resolution skills;
7. Adaptability to new environments and strong learning ability.

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