Factory Operations Lead - บริษัท ไอเมด ลาบอราทอรี่ จำกัด

IMED is looking for an experienced and capable Factory Operations Lead to oversee factory operations, production management, quality systems, people management, and continuous improvement. The successful candidate will be responsible for ensuring efficient factory operations in compliance with company standards, applicable quality systems, and relevant regulatory requirements.

Key Responsibilities

• Manage and oversee overall factory operations, including production, quality, manpower, machinery, raw materials, facilities, and other resources.
• Plan and control production activities to achieve targets in terms of quality, quantity, cost, productivity, and on-time delivery.
• Supervise the entire production process, from incoming materials, manufacturing and quality inspection to packaging, storage, and product delivery.
• Improve production processes to increase efficiency, reduce waste and costs, and enhance productivity.
• Ensure factory operations comply with applicable quality management systems, particularly ISO 13485, ISO 9001, and other relevant standards and requirements.
• Participate in the preparation, review, implementation, and control of SOPs, Work Instructions, Quality Procedures, Production Records, and Quality Management System documentation.
• Oversee quality-related activities, including CAPA, Nonconformity Management, Change Control, Risk Management, Validation, and Traceability.
• Analyze production and operational problems, conduct Root Cause Analysis, and establish effective corrective and preventive actions.
• Prepare the factory for Internal Audits, External Audits, Certification Audits, and inspections by relevant authorities.
• Manage machinery, production equipment, tools, preventive maintenance, calibration, and equipment readiness.
• Control inventories of raw materials, consumables, work-in-process, and finished goods in accordance with production requirements.
• Ensure appropriate control of production areas, workplace conditions, cleanliness, safety, and factory organization.
• Plan manpower requirements, assign responsibilities, monitor performance, and evaluate factory employees.
• Coach, train, and develop employees to ensure they have the knowledge and competencies required to perform their duties effectively.
• Establish, monitor, and analyze factory and departmental KPIs, and develop improvement plans where necessary.
• Prepare operational reports covering performance, issues, risks, corrective actions, and factory development plans for management review.
• Manage new projects, including new production processes, new products, machinery installation, production capacity expansion, and factory improvement projects.
• Coordinate with relevant departments, including Quality, R&D, Warehouse, Purchasing, Engineering, Sales, Regulatory Affairs, HR, and Management.
• Perform other duties as assigned to support the company’s operational and business objectives.

Qualifications

• Bachelor’s degree or higher in Medical Technology, Science, or other related fields.
• Candidates with a degree in Medical Technology will be given special consideration.
• Experience in manufacturing, factory management, production management, or related operational functions.
• Experience in a supervisory or managerial role, such as Factory Operations Lead, Production Lead, or equivalent management position.
• Experience in the medical device, laboratory product, diagnostic kit, diagnostic reagent, or medical/scientific product industry will be an advantage.
• Good knowledge and understanding of Quality Management Systems, particularly ISO 13485 and other relevant ISO standards.
• Knowledge of quality documentation, production process control, traceability, and risk management.
• Strong analytical and systematic problem-solving skills, including knowledge of Root Cause Analysis, CAPA, and Continuous Improvement.
• Strong skills in production planning, project management, cost control, and operational efficiency management.
• Strong leadership and people management skills, with the ability to supervise, motivate, and develop teams.
• High level of responsibility, discipline, organization, and sound decision-making ability.
• Strong communication and cross-functional coordination skills, including the ability to present and report to management.
• Good computer skills, including Microsoft Office and other systems relevant to factory operations.
• Able to work permanently in Rayong Province.

Preferred Qualifications

Candidates with any of the following qualifications will be given special consideration:

• Bachelor’s degree or higher in Medical Technology.
• Experience in a medical device manufacturing facility or laboratory-related manufacturing environment.
• Hands-on experience with ISO 13485.
• Experience in preparing a factory for audits, certification, or regulatory inspections.
• Experience in establishing or implementing factory operations or Quality Management Systems.
• Experience with Validation, Risk Management, CAPA, Process Improvement, or Continuous Improvement.
• Experience managing production teams, quality teams, or multiple functions within a factory.
• Knowledge of medical device regulatory requirements and related compliance systems.

Key Competencies

Leadership • Production Management • Quality Management • Problem Solving • Planning • Cost Control • People Management • Continuous Improvement • Risk Management • Project Management

          We are looking for a Factory Operations Lead who can serve as an operational leader, quality-driven manager, and factory development leader — someone who can turn plans into measurable results and build a strong team that grows together with the organization.

i+MED, we are a complete healthcare provider: manufacturing and distributing

Our key areas of operations include the production of rapid diagnostic test kits for medical purposes, which employ the Chromatographic Immunoassay principle as a high-quality screening tool to detect antibodies, antigens, or hormones in samples taken from humans, animals, plants, or certain substances found in food and raw materials.

• Manufacturing screening test kits that meet global standards.
• Medical instruments distributor from leading brands.
• Leader in medical information systems and technologies.

Because we have good standards, criteria and methods in the production of medical devices.(GMP for Medical Devices) and certified medical device quality management system
EN ISO13485 : 2016, ISO 13485, ISO 9001, ISO/IEC 27001