Quality Technician - Medical Devices (GMP/QC)

Sterling Engineering Ltd - Ireland & Europe; Sligo; On-site; EUR 32,000 - 42,000; Full time

Job summary

Sterling Engineering Ltd in Ireland seeks a Quality Technician for Medical Devices to join the Quality Assurance team. The role focuses on maintaining cGMP compliance, supporting QA activities, and ensuring quality events are managed effectively.

The incumbent will operate within QC/IQA and Metrology areas, conduct tests per specifications, and contribute to continuous improvement and documentation control across the site.

Qualifications

• A third level qualification in an appropriate discipline is desirable.
• 2+ years’ experience within a regulated GMP environment.
• Experience with day-to-day operation of a quality system in a regulated combination product/device manufacturing environment is desirable.

Responsibilities

• Join the Quality Team to ensure Quality goals and objectives are achieved.
• Ensure compliance with current good manufacturing practices (cGMP).
• Operate within QC/IQA and Metrology areas as required.
• Complete incoming product testing per approved specifications and procedures.
• Complete in-process and final release product testing per approved specifications and procedures.
• Inform management of all Quality Events or potential Quality Events.
• Maintain thorough, complete, and compliant Quality System documentation.
• Audit the quality system with other personnel as required.
• Support Change Management Process including product and Quality System document reviews and updates.
• Generate and provide metrics for management review, monthly reports and overall Quality Performance.
• Ensure training requirements are maintained.
• Participate in continuous improvement programs to enhance quality, safety, environmental and production systems.
• Generate batch records for manufacturing support as required.
• Complete disposition decisions for incoming material

Skills

Attention to detail

GMP compliance

Quality systems

Documentation

Education

Bachelor's degree or equivalent (relevant discipline)

Job description

Sterling Engineering Ltd in Ireland seeks a Quality Technician for Medical Devices to join the Quality Assurance team. The role focuses on maintaining cGMP compliance, supporting QA activities, and ensuring quality events are managed effectively.

The incumbent will operate within QC/IQA and Metrology areas, conduct tests per specifications, and contribute to continuous improvement and documentation control across the site.