Our Client, A leading Medical Device company based in Clare, are seeking a Manufacturing Technician to join their team. The Manufacturing Technician will manufacture products in compliance with all quality and safety requirements, provide manufacturing support to process & product development, support process improvements, and support validation activities within the company.
Responsibilities include but are not limited to:
- Manufacture of products both onsite and at subcontractors/suppliers to ensure that the product quality, regulatory & business requirements are met.
- Provide Manufacturing support to R&D to develop and improve process and product development projects.
- Creation, update and review of documentation including Batch records, procedures etc.,
- Ensure all items of equipment are maintained following the maintenance and calibration procedures and schedules.
- Ensure all health, safety and environmental requirements are met.
- Track and report progress across projects by reviewing schedules and due dates, identifying risks and implementing contingency plans.
- Support the Quality Management System through resolution of NCR, NCM's and CAPAs ensuring effective solutions are implemented.
- Stock and inventory management using the ERP system.
- Support Validation Activities including execution of protocols for equipment and process validations.
- Review and contribute to supplier process validation and risk management activities.
- Introduce, Assess and approve process changes ensuring product impact is appropriately considered.
- Provide support during internal and external audits.
- Compile any necessary equipment/capital authorization requests supported with appropriate justifications and alternative options.
- Carry out process and safety risk assessments, and pFMEAs.
- Communicate effectively with all Internal & External Stakeholders.
- Collaborate with key suppliers and their production/manufacturing teams to drive and support process/product improvements/developments.
