Job Summary:

The Process Technician will be responsible for maintaining, monitoring, and improving manufacturing processes within the medical device production environment. This role involves working closely with the production, quality and engineering team to ensure that all processes comply with regulatory standards and quality requirements.

Essential Duties and Responsibilities:

Include the following:

• Monitor and Control Processes: Oversee daily operations of manufacturing processes to ensure efficiency and compliance with quality standards/SOP.
• Identify training requirements and train production personnel in accordance with company, department, ISO, and GMP guidelines.
• Support and run engineering study to evaluate process improvement ideas.
• Review and implement supporting documentation including DHR’s, MPI’s, SOP’s, & ECO’s.
• Troubleshooting: Identify and resolve issues with production equipment and processes to minimize downtime and maintain product quality.
• Process Improvement: Collaborate with engineers to develop and implement process improvements that enhance productivity and reduce waste.
• New Product Introduction (NPI): Assist in the transition of new products from development to manufacturing, ensuring that all processes are optimized for production
• Work with Process and Manufacturing Engineering to develop and refine processes for production.
• Work as part of production support team to drive process improvements.
• Sustainability Engineering: Implement and support initiatives aimed at reducing environmental impact, such as waste reduction, energy efficiency, and sustainable material usage
• Documentation: Maintain accurate records of process parameters, production data, and any deviations from standard operating procedures. Assist in conducting IQ/OQ/PQ process. Assist in the creation and maintenance of up-to-date SOPs.
• Quality Assurance: Conduct regular inspections and tests to ensure products meet all regulatory and quality standards.
• Training: Assist in training new employees on standard operating procedures and safety protocols.
• Safety Compliance: Ensure all safety guidelines are followed and address any potential hazards promptly.
• Maintain and comply with ISO13485, GMP and FDA regulations.
• Required to perform rotating shift duties, including evening and night shifts, and may be assigned different roles within the team to support operational needs.
• Any other project or duties as assigned.

Authority:

NA

Education/Experience and Qualifications:

• GCE “O” level or higher with 1-3 years assembly or technician experience preferably in medical device.
• Computer literacy required. Familiar with Microsoft office software and AutoCAD a plus.
• Knowledgeable in writing manufacturing procedures and GMP requirements.
• Knowledgeable in GMP, ISO, cleanroom procedures, and documentation.
• Good technical knowledge and understanding of broad scope of manufacturing processes.
• Excellent communication skills.
• Environmental Health & Safety Training is desired but not essential.