Quality Engineer

Desired Skills: MS Office Suite,Science,Engineering,Microbiology,GMP,compliance

The Role

PE Global are recruiting for a Quality Engineer for our medical device client based in Galway. This is an initial 12-month contract role. Hybrid working options.  

Job Responsibilities

• Support routine Sterility Assurance activities e.g GMP, Standards Compliance, Cleanroom Risk Assessment, Limits review, Dose Audit activity, Cycle Requalification, Supplier Change control etc

• Support sterility assurance activities for new products and change control, developing strong partnering relationships with these groups, at both manufacturing and design sites
• Participate in root cause investigations and continuous improvement in day-to-day activity, initiating appropriate corrective actions and following through to implementation

• Support cross functional teams in design protocols to ensure that new products/ product changes are adequately evaluated/tested to guarantee compliance to all regulatory standards
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• Performs calculations, data integrity checks, technical and record keeping duties in conformance with company and regulatory policies and standards to meet quality and accuracy requirements
• Adhere to all relevant site wide procedures and practices for Safety & GMP

Education & Experience

• Bachelor’s degree (Level 8 NFQ) in Science/ Microbiology or related discipline.
• 1-2 years relevant experience in a medical devices or related environment preferred.
• Dynamic team player who can work effectively and proactively on cross functional teams.
• Good communicator and fluent in English, both in writing and speaking

Interested candidates should submit an updated CV.

Please click the link below to apply, alternatively send an up-to-date CV aisling.oleary@peglobal.net

****Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****