Production Manager

A Production Manager in a plastic injection moulding manufacturing facility with experience in cleanroom and control room environments is responsible for overseeing the entire production process. This includes ensuring that products, particularly for automotive and medical industries, meet stringent quality and regulatory standards. The manager will optimize production operations, manage resources, and ensure compliance with cleanroom protocols while maintaining safety, quality, and efficiency.

Key Responsibilities:

Production Planning and Execution:

• Plan, schedule, and oversee all aspects of plastic injection moulding production, ensuring that operations run efficiently and meet production goals.
• Monitor production performance and output, adjusting resources and schedules as needed to meet deadlines for automotive and medical products.
• Ensure the manufacturing processes adhere to cleanroom and control room standards, especially for medical products requiring sterile conditions.

Cleanroom and Control Room Management:

• Manage operations in the cleanroom environment, ensuring adherence to strict contamination control protocols (e.g., ISO 14644 or FDA standards for medical devices).
• Oversee production in controlled environments where air quality, humidity, and temperature are closely regulated, ensuring compliance with regulatory and quality standards.
• Ensure all production processes meet the requirements for automotive (IATF 16949) and medical (ISO 13485) industries, including traceability, sterility, and cleanliness.

Quality Assurance and Compliance:

• Ensure that all production processes meet the required quality standards and regulations for the automotive and medical industries, including FDA compliance, ISO 9001, IATF 16949, and ISO 13485.
• Collaborate closely with the QA and regulatory teams to ensure all products meet stringent quality requirements, particularly medical devices that need sterilization and validation.
• Implement corrective actions and continuous improvement initiatives to address quality issues and reduce defects in both automotive and medical product lines.

Team Leadership and Training:

• Lead and manage the production team, including supervisors, technicians, operators, and cleanroom personnel, ensuring they are trained in proper procedures and safety protocols.
• Allocate tasks and resources effectively to meet production targets while maintaining quality standards.
• Provide ongoing training and mentorship to the production team on cleanroom protocols, safety practices, and industry-specific standards.

Production Process Optimization:

• Identify areas for process improvement and implement lean manufacturing practices to optimize efficiency, reduce waste, and increase production capacity.
• Oversee the use of statistical process control (SPC) and other methods to monitor process efficiency and minimize downtime.
• Implement automation technologies and advanced manufacturing techniques to improve production flow and product consistency.

Resource and Inventory Management:

• Manage resources, including raw materials, machinery, and labor, to meet production demands for both automotive and medical product lines.
• Ensure that the necessary cleanroom supplies, including protective clothing, sterilization materials, and cleaning agents, are available and properly managed.
• Coordinate with the procurement team to ensure timely availability of materials and components, maintaining optimal inventory levels without overstocking.

Health, Safety, and Environmental Compliance:

• Ensure that the production floor and cleanroom environments meet all health, safety, and environmental regulations.
• Promote a strong safety culture, ensuring that all employees follow safety protocols, including the use of personal protective equipment (PPE) in the cleanroom.
• Conduct regular safety audits and risk assessments, addressing any hazards or non-compliance issues in the production environment.

Maintenance and Equipment Management:

• Oversee the maintenance and repair of injection moulding machines and auxiliary equipment, ensuring minimal downtime and maximum efficiency.
• Implement a preventive maintenance program to keep equipment in optimal working condition, particularly in the controlled environments of the cleanroom and control room.
• Collaborate with the toolroom and maintenance teams to resolve any technical issues related to moulds, tools, and machinery used in production.

Customer and Stakeholder Collaboration:

• Work closely with customers, particularly in the automotive and medical sectors, to ensure production meets their specifications and delivery schedules.
• Address customer concerns and feedback related to production quality and timelines, implementing corrective measures when necessary.
• Provide regular updates and reports to senior management on production performance, quality metrics, and compliance with industry regulations.

Qualifications and Skills:

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related field.
• Additional certifications such as Six Sigma, Lean Manufacturing, or ISO 13485 certification for medical devices is a plus.
• 7+ years of experience in plastic injection moulding manufacturing, with at least 3+ years in a managerial role.
• Experience in working within cleanroom environments and control rooms for the production of medical and automotive products.
• Familiarity with FDA, ISO 9001, IATF 16949, ISO 13485, and other relevant standards for automotive and medical manufacturing.
• Strong understanding of injection moulding processes, mould setup, and troubleshooting.
• Proficient in statistical process control (SPC), lean manufacturing, and Six Sigma methodologies to drive process improvements.
• Knowledge of cleanroom and control room operations, including air filtration, sterilization, and contamination control.
• In-depth knowledge of regulations and compliance requirements for both the automotive and medical device industries.
• Familiarity with cleanroom protocols, including ISO 14644 standards for air cleanliness and sterility.
• Strong verbal and written communication skills, capable of interacting with customers, suppliers, and cross-functional teams.
• Ability to present complex production and quality data in a clear and concise manner to senior management.