Job Description

The Production Manager is responsible for managing all aspects of production operations, ensuring that production processes are compliant with company policies, safety requirements, quality requirements, and regulatory requirements. This role involves leading production teams, managing production plans, and promoting production efficiency and continuous improvement. The Production Manager will oversee the Production team and provide strategic direction and leadership to the entire production department.

Work Environment:
Frequently exposed to moving mechanical parts.
Moderate noise level.
Controlled Environment (Class 10K/100K cleanroom) and office area.
Position Location
QSG Singapore
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 a goal of 0 audit findings.
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, ensuring actual practices follow documented procedures 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.
Requirements
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.
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