Production Engineer

2 days ago

Delhi, Delhi, India Excellence Medical Care - شركة تميز الرعاية الطبية Full time US$ 9,00,000 - US$ 12,00,000 per year

We are seeking an experienced Production Engineer with a solid background in medical manufacturing or a similar regulated industry to join our team in Saudi Arabia. The ideal candidate will be responsible for overseeing production operations, with a strong focus on cleanroom design and implementation, regulatory compliance, and technical documentation. The role involves working closely with contractors, government entities, and internal departments to ensure the facility meets industry and regulatory standards, particularly ISO 13485.

Workplace: Kingdom of Saudi Arabia – Eastern Province – Dammam

Key Responsibilities:
• Cleanroom Design & Execution:
• Lead the design and layout of ISO-compliant cleanrooms tailored for medical manufacturing.
• Supervise the execution and construction of cleanrooms, coordinating with contractors and suppliers.
• Ensure all cleanroom specifications comply with regulatory and operational requirements.
• Regulatory & Government Liaison:
• Communicate and coordinate with relevant governmental authorities in Saudi Arabia to ensure all regulatory and licensing requirements are met.
• Support site inspections, documentation, and compliance activities with local and national regulatory bodies.
• Production Process Development:
• Develop, implement, and optimize production processes to ensure safety, efficiency, and high product quality.
• Prepare detailed Standard Operating Procedures (SOPs) and production manuals for manufacturing activities.
• Support technology transfer and scale-up of new products or processes.
• Quality & ISO Compliance:
• Ensure adherence to ISO 13485 and other applicable regulatory standards.
• Participate in audits, nonconformance investigations, and corrective/preventive actions.
• Project & Cross-functional Support:
• Contribute to company-wide projects and sub-tasks related to manufacturing and process improvement.
• Work closely with departments including R&D, Quality, and Supply Chain to align production goals with overall company objectives.

⸻

Qualifications:
• Bachelor's degree in Mechanical, production, Industrial, or a related Engineering field.
• Minimum of 5 years of experience in medical device manufacturing, pharmaceutical production, or a related regulated industry.
• Hands-on experience.
• Strong understanding of ISO 13485 and medical manufacturing regulations.
• Experience working with regulatory bodies in Saudi Arabia or the GCC region is a strong plus.
• Excellent project management, documentation, and communication skills.
• Ability to work independently in a fast-paced and regulated environment.

⸻

Preferred Qualifications:
• Previous experience setting up new production facilities or supporting facility commissioning.
• Certification in project or quality management (e.g., PMP, Six Sigma) is an advantage.

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