Job Description

The Factory Manager will oversee all aspects of the manufacturing operations within the medical devices facility, ensuring compliance with regulatory standards, meeting production targets, and maintaining high quality and safety standards. This role will involve leadership, strategic planning, and continuous improvement initiatives to enhance operational efficiency and drive the success of the manufacturing process.

Key Responsibilities:

1. Operations Management

:

- Oversee daily manufacturing operations to ensure efficient and timely production of medical devices.

- Develop and implement production schedules to meet customer demand and ensure optimal resource utilization.

- Monitor production processes and equipment performance, making adjustments as necessary to improve efficiency and reduce downtime.

2. Quality Assurance:

- Ensure compliance with all relevant regulatory standards (e.g., FDA, ISO 13485) and internal quality management systems.

- Implement and enforce quality control procedures to maintain high product quality and safety standards.

- Lead investigations into product quality issues and implement corrective and preventive actions (CAPA).

3. Team Leadership and Development:

- Manage and lead a diverse team of manufacturing staff, fostering a culture of collaboration, safety, and continuous improvement.

- Conduct regular performance evaluations, provide feedback, and identify training needs for team members.

- Promote employee engagement and retention through effective communication and professional development opportunities.

4. Continuous Improvement:

- Drive continuous improvement initiatives using Lean, Six Sigma, or other methodologies to enhance operational efficiency and reduce waste.

- Analyze production metrics and data to identify areas for improvement and implement solutions accordingly.

- Encourage innovation in manufacturing processes and technology adoption to enhance productivity.

5. Supply Chain Coordination:

- Collaborate with supply chain and procurement teams to ensure timely availability of raw materials and components needed for production.

- Monitor inventory levels and coordinate with logistics to optimize material flow and reduce lead times.

6. Safety and Compliance:

- Ensure a safe working environment by enforcing safety protocols and conducting regular safety audits.

- Maintain compliance with environmental regulations and company policies related to waste management and sustainability practices.

7. Budgeting and Cost Control:

- Develop and manage the factory budget, ensuring efficient allocation of resources and cost control measures.

- Analyze financial performance and implement strategies to improve profitability.

8. Reporting and Communication:

- Prepare and present regular reports to senior management on production performance, quality metrics, and operational challenges.

- Collaborate with other departments (R&D, regulatory, sales) to align manufacturing capabilities with business objectives.

Qualifications:

- Bachelor's degree in Engineering, Manufacturing, Operations Management, or a related field; a Master's degree or MBA is preferred.

- Minimum of 5-7 years of experience in manufacturing management, preferably in the medical device or regulated industry.

- Strong knowledge of manufacturing processes, quality assurance, and regulatory requirements in the medical device sector.

Skills:

- Excellent leadership and team management skills.

- Strong analytical and problem-solving abilities.

- Proficiency in production planning, inventory management, and quality control techniques.

- Familiarity with Lean manufacturing and continuous improvement methodologies.

- Effective communication and interpersonal skills, with the ability to collaborate across departments.

- Proficient in using ERP systems and manufacturing software.

Performance Expectations:

- Achieve production targets and quality standards consistently.

- Maintain high levels of employee engagement and low turnover rates.

- Ensure compliance with regulatory standards and successful audits.

- Drive continuous improvement initiatives leading to measurable operational efficiencies.

Job Type: Full-time

Pay: RM3,500.00 - RM4,500.00 per month

Ability to commute/relocate:

Kajang: Reliably commute or planning to relocate before starting work (Required)
Education:

Bachelor's (Preferred)
Work Location: In person