Job Summary:

Essential Duties and Responsibilities:

• Oversee the entire production operation to ensure compliance with company policies and regulatory requirements.
• Develop and implement production strategies to achieve company objectives and production targets.
• Review production orders and plans to ensure qualified products are produced within schedule.
• Lead teams to analyze production variances and take effective corrective actions.
• Push for equipment management and maintenance to support production plans.
• Promote lean manufacturing and continuous improvement initiatives using VSM, cell line, and other lean tools.
• Monitor quality checks and resolve production quality issues, ensuring compliance with ISO13485, ISO9001, and FDA regulations. Lead FDA inspection and external audits related to production ownership areas with 0 audit findings goal.
• Manage labor and maintain a safe and efficient work environment, leading 5S and EHS activities in the production department.
• Train and motivate production teams, ensuring timely completion of work and continuous skill development.
• Participate in management reviews and coordinate with other departments to achieve production goals.
• Drive department performance through production and quality metrics such as output yield (FPY, FY), production schedule OTD, daily fill rates, and cost control.
• Ensure effective resource allocation, including labor, materials, and equipment.
• Support process refinements, qualifications, and validations, including equipment and material specifications.
• Ensure complete and accurate documentation of production processes.
• Ensure all procedures under production ownership are effective and efficient, making sure actual practices follow documents with zero gaps.
• Conduct regular workplace inspections to identify and rectify unsafe conditions.
• Oversee health and safety within the production department, including accident investigation and corrective actions.
• Ensure environmental aspect and safety hazard risk assessments are conducted and controlled.
• Report all occupational accidents and incidents immediately and support EHS Committee Management Representative in investigations.
• Enforce compliance with EHS management systems and relevant legal and other applicable EHS requirements.
• Provide leadership and direction in EHS internal and external audits.
• Coordinate and communicate with other departments to support production goals.