Production Manager (Medical Appliances)

FUSHAN MEDICAL APPLIANCES (MALAYSIA) SDN. BHD.; Kulai; On-site; MYR 150,000 - 200,000; Full time

Job summary

A leading medical devices manufacturer located in Johor is seeking a Production Manager. This role involves overseeing daily operations, ensuring compliance with ISO and GMP standards, and managing a production team. Candidates should have a Bachelor's degree related to medical devices or production management, with a minimum of 5 years of relevant experience. Proficiency in English and Malay is essential, and knowledge of Mandarin is advantageous. The company offers career advancement opportunities, medical benefits, and a stable work environment.

Benefits

Statutory public holidays

Medical benefits

Annual leave entitlements

Career advancement opportunities

Exposure to international environment

Qualifications

• Minimum of 5 years of production management experience in manufacturing.
• Experience managing cleanrooms is preferred.
• Professional proficiency in English and Malay; Mandarin is a plus.

Responsibilities

• Develop and execute production plans, optimizing processes for quality and compliance.
• Lead the production team, fostering a culture of continuous improvement.
• Ensure compliance with regulatory requirements and manage quality audits.

Skills

Production management

Lean manufacturing principles (5S, TPM)

Leadership skills

Problem-solving skills

Strong communication skills

Education

Bachelor’s degree in Biomedical/Medical Device Engineering

Production Management or Business Administration

Tools

ISO 9001 quality management systems

ISO 13485

GMP compliance

Job description

About the role

The role is fully responsible for the daily operations of the production department, driving efficiency improvements, quality control, and cost management. All production activities must strictly comply with the medical device quality management system (ISO 13485), GMP (Good Manufacturing Practice), and relevant regulations (e.g., FDA).

Responsibilities

• Production & Operations Management: Develop and execute production plans, optimize manufacturing processes, and ensure timely, quality, and quantity-compliant order fulfillment.
• Oversee the daily operations of cleanrooms, including environmental controls and personnel behavior management.
• Implement lean manufacturing principles and tools (e.g., 5S, TPM) to continuously improve production efficiency and reduce operational costs.
• Quality & Compliance: Ensure all production activities fully comply with ISO13485, GMP, and regulatory requirements from the Malaysian Medical Device Authority (MDA) and international bodies (e.g., FDA).
• Work closely with the QA/QC department to handle non-conformities in production and on-site issues, leading the implementation of corrective and preventive actions (CAPA).
• Manage production-related validation and verification activities (e.g., equipment, process, and cleaning validation) and support customer and third-party quality system audits.
• Team & Safety Management: Lead, train, and motivate the production team, fostering a culture of continuous improvement and excellence in quality.
• Oversee staff training, performance evaluations, and career development planning for production personnel.
• Enforce environmental, health, and safety policies rigorously, ensuring a zero-incident, safe production environment.

Job Requirements

• Bachelor’s degree in Biomedical / Medical Device Engineering, Production Management, Business Administration, or a related field.
• Willing to be assigned to the company headquarters for a 2 to 3-month training period.
• Minimum of 5 years of production management experience in the manufacturing industry; experience managing cleanrooms is preferred.
• Proficient in ISO 9001 quality management systems and production management tools such as 5S and TPM. Familiarity with ISO 13485, GMP, and other medical device quality management systems is required; practical experience handling MDA/FDA audits is a plus.
• Strong leadership, communication, problem-solving, and team management skills.
• Professional proficiency in English and Malay, with proficiency in Mandarin, as the role involves liaising with China-based clients while handling local government and regulatory matters in English and Malay.
• Detail-oriented, highly responsible, and compliance-conscious.

What we offer

• Statutory public holidays and annual leave entitlements.
• Medical benefits, allowances, and annual medical check-ups.
• EPF, SOCSO, and EIS statutory contributions.
• Opportunities for career advancement in a fast-growing medical device manufacturing company.
• Exposure to an international working environment, including cross-border collaboration and training.
• A stable and professional workplace with strong emphasis on quality, safety, and continuous improvement.

About us

FUSHAN MEDICAL APPLIANCES (MALAYSIA) SDN. BHD. is a medical consumables manufacturer located in Senai, Johor, dedicated to producing high-quality medical devices that meet stringent standards. We are equipped with advanced cleanroom facilities and a rigorous quality management system, providing reliable assurance for human health.

Apply now to become our next Production Manager.