Quality Assurance Technician - Medical Devices

About the Role

PE Global is seeking a Quality Assurance Technician on a 12-month contract to work at our Medical Device client’s site in Sligo, Ireland. This role will be part of the Quality Team ensuring the achievement of quality objectives while strictly adhering to current good manufacturing practices (GMP).

Key Responsibilities

• Collaborate with the Quality Team to meet designated quality goals and objectives.
• Operate within QC, IQA, and Metrology areas as needed.
• Perform testing on incoming products, in-process, and final release products following approved specifications and procedures.
• Report all quality events or potential quality issues related to products or processes to management promptly.
• Maintain comprehensive, complete, and compliant Quality System documentation.
• Conduct audits of the quality system alongside other personnel when required.
• Support the Change Management Process, including review and updates of product and quality system documents.
• Prepare and provide metrics for management reviews, monthly reports, and overall quality performance assessments.
• Ensure compliance with all training requirements.
• Participate actively in continuous improvement initiatives aimed at enhancing quality, safety, environmental, and production systems at the site.
• Generate batch records as necessary to support manufacturing process orders.
• Make disposition decisions regarding incoming materials.

Essential and Desired Qualifications

• Preferably holds a third level qualification in a relevant discipline.
• At least 2 years of experience within a regulated GMP environment is advantageous.
• 1+ years’ experience working within a quality system of a regulated combination product/device manufacturing environment is desirable.

Candidate Profile and Expectations

• Must demonstrate high attention to detail and strong mental focus to ensure full compliance with operating procedures and regulatory requirements.
• Ability to adapt to frequently changing processes is required.
• Shows unwavering commitment to quality and safety at all times.
• Exhibits a personal responsibility to align with the organization's vision, strategic goals, and operational pillars.
• Possesses good knowledge of company policies and procedures, working towards meeting organizational goals.
• Practices a "Right First Time" work ethic consistently.
• Follows all policies, procedures, and guidelines ensuring compliance with cGMP, ISO, FDA regulations, and company standards.
• Demonstrates tenacity and attention to detail in escalating any identified issues to the Operations Quality Team Leader.
• Maintains strict adherence to cGMP standards continuously.
• Exercise constant vigilance to detect and prevent errors through careful and careful attention.