JOB DETAILS

JOB DETAIL

- Oversee and manage all production operations to ensure compliance with quality, safety, and regulatory standards specific to medical device manufacturing (e.g., ISO 13485, FDA).
- Develop and implement efficient production plans, schedules, and workflows to meet output, quality, and delivery targets.
- Coordinate with Quality Assurance, Engineering, and Regulatory teams to maintain product integrity and ensure production processes align with compliance requirements.
- Monitor production metrics, analyze performance data, and implement continuous improvement initiatives (e.g., Lean Manufacturing, Six Sigma).
- Manage and develop production staff through training, performance evaluation, and capacity planning to optimize productivity and skill development.
- Lead investigations into production issues or deviations and implement corrective and preventive actions (CAPA) as required.
- Other assigned by MD

REQUIRED WORK EXPERIENCE

- Bachelor’s Degree in related field or high vocational with 5 years experiences
- Minimum of 5 years of experience in production supervision, preferably in the medical device industry.
- Knowledge of quality control systems and regulations (e.g., ISO 13485)
- Ability to analyze data and implement process improvements
- Excellent communication and organizational skills
- Good command of English. Japanese language skills are a plus