Production Manager - #1097036

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

·        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.

Authority:

• Approve production schedules, plans, and resource allocations.

• Enforce compliance with company policies, ISO13485, ISO9001, and FDA regulations.

• Authorize equipment maintenance and technical support to ensure production efficiency.

• Lead and implement lean manufacturing and continuous improvement projects.

• Conduct and approve quality checks and corrective actions for production issues.

• Manage and approve labor allocation, overtime, and shift schedules.

• Oversee and enforce 5S and EHS activities within the production department.

• Approve training programs and ensure compliance with industry regulations.

• Participate in hiring, appraising, and disciplining production staff.

• Implement corrective and preventive actions for EHS non-conformance.

• Coordinate and communicate with other departments to support production goals.

• Make strategic decisions to optimize production processes and achieve company objectives.

Education/Experience and Qualifications:

• Degree or above with at least 5 years of relevant work experience.

• Strong analytical skills, solutions- and process-oriented, organized, and structured.

• Focus on continuous improvement, self-directed, and results-oriented.

• Proficient in failure & root cause analysis and corrective action deployment.

• Knowledge of Lean manufacturing and Six Sigma is preferred.

• Excellent communication and production management skills.

·        Familiarity with medical device standards and regulations, including ISO 13485 and FDA 21CFR.