Factory Manager Medical Devices
Location: Nihon Kohden, UAE Dubai Airport Free Zone (DAFZA)
Job Summary
The Factory Manager will lead and oversee all operations of Nihon Kohdens UAE facility, ensuring seamless production and compliance with international medical device manufacturing standards. This role is central to maintaining operational excellence, driving efficiency, and aligning regional operations with global strategies.
The successful candidate will manage cross-functional teamsincluding Production, Quality Assurance (QA), Regulatory Affairs (RA), Quality Control (QC), Warehouse, Factory Accounting, Administration, and Logisticswhile ensuring strict adherence to medical device regulatory frameworks and the highest quality standards.
Key Responsibilities
Operational Leadership
- Direct day-to-day factory operations, ensuring production schedules, quality standards, and delivery timelines are consistently achieved.
- Implement and enforce global operating procedures, technical guidelines, and compliance requirements.
Production & Quality Excellence
- Oversee production planning and execution to meet business objectives.
- Ensure adherence to Good Manufacturing Practices (GMP), ISO 13485, and other applicable medical device standards.
- Monitor KPIs, analyze variances, and apply corrective actions for continuous improvement.
Regulatory & Compliance Oversight
- Lead the preparation and submission of technical, regulatory, and quality documentation in alignment with UAE and international standards (SFDA, EU MDR, FDA, etc.).
- Ensure audit readiness and support both internal and external inspections.
Cross-Functional Management
- Collaborate closely with global HQ and regional teams to align strategies, projects, and technology transfers.
- Lead factory staff development through training, mentorship, and performance management.
Innovation & Efficiency
- Identify and implement operational improvements to enhance manufacturing efficiency and interdepartmental collaboration.
- Introduce advanced processes and lean manufacturing techniques to optimize cost-effectiveness and scalability.
Candidate Profile
Education:
- Bachelors degree in Engineering, Industrial/Manufacturing, or a related field.
- Advanced certifications in Project Management, Lean Six Sigma, or Risk Management highly desirable.
Experience:
- Minimum 1015 years in manufacturing leadership, with at least 57 years in medical devices or life sciences.
- Proven expertise in regulated manufacturing environments (ISO 13485, GMP).
- Demonstrated success managing distributors and operations across multiple countries is a plus.
Skills & Competencies:
- Strong technical understanding of medical device manufacturing processes and regulatory landscapes.
- Excellent leadership and team management skills with a collaborative, hands-on approach.
- Ability to liaise effectively with cross-border teams and global stakeholders.
- Strong analytical, problem-solving, and decision-making abilities.
- High-level communication and organizational skills, with fluency in English (Arabic is an advantage).
