Quality Technician, Medical Devices - GMP & Compliance

Sterling Engineering Ltd - Ireland & Europe; Sligo; Sur place; EUR 35 000 - 52 000; Plein temps

Résumé du poste

Sterling Engineering Ltd - Ireland & Europe is seeking a Quality Technician for Medical Devices to join the Quality Assurance team. The role emphasizes GMP compliance, testing at incoming, in-process and final release stages, and working within QC/IQA and Metrology areas.

You will maintain Quality System documentation, support change management, and contribute to continuous improvement and EHS initiatives on site.

Qualifications

• A third level qualification in an appropriate discipline is desirable.
• 2+ years’ experience within a regulated GMP environment.
• 1 year plus experience in the day-to-day operation of the quality system in a highly regulated combination product/device manufacturing environment is desirable.
• The role requires a high level of attention to detail and the ability to adapt to new processes.
• Total commitment to quality and safety in all duties.

Responsabilités

• Work as a member of the Quality Team to achieve quality goals.
• Ensure compliance with current good manufacturing practices.
• Operate within the QC/IQA and Metrology Areas, as required.
• Complete incoming product testing per the relevant approved specifications and procedures.
• Complete in-process and final release product testing per the relevant approved specifications and procedures.
• Keep Management informed of Quality Events or potential Quality Events.
• Ensure Quality System documentation is thorough, complete, and compliant.
• Audit the quality system with other personnel where required.
• Support Change Management Process including Product and Quality System document review and updates.
• Generate and provide metrics for inclusion in management review and monthly reports.
• Ensure compliance with training requirements is maintained.
• Participate in continuous improvement programs to implement improvements in quality, safety, environmental and production systems.
• Generate batch records for as required in support of manufacturing process orders.
• Complete disposition decisions for incoming material.

Connaissances

Quality system operation

Attention to detail

Regulatory compliance

cGMP knowledge

Formation

Third level qualification in an appropriate discipline

Description du poste

Sterling Engineering Ltd - Ireland & Europe is seeking a Quality Technician for Medical Devices to join the Quality Assurance team. The role emphasizes GMP compliance, testing at incoming, in-process and final release stages, and working within QC/IQA and Metrology areas.

You will maintain Quality System documentation, support change management, and contribute to continuous improvement and EHS initiatives on site.