QA Specialist Medical Devices

Matrix Recruitment

Wicklow, Dublin South

What you need to know. You will work as a Quality Specialist for our client in the medical devices industry based in South Dublin. As the Quality Specialist, you will be responsible for supporting the manufacture of product at the Contract Manufacturing Organisation (CMO) sites, under the management of Quality Operations. The role involves ensuring products are evaluated and any issues are investigated for the preparation for QP release for products manufactured and to undertake activities relating to processes, systems and supporting activities. This is a Full-time, permanent role with a negotiable salary. Must be available to work beyond normal office hours and weekends. Good opportunities within this company. Your new job. Key duties & responsibilities: Foster and promote GMP, GDP and the associated Quality Management Systems within the site. Review Finished Batch Record and GMP Release for final QP Release. Support ongoing preparation for Regulatory and Client audits, ensuring timely audit response and completion of agreed actions on time. Oversee and input to CMO related Change Control, Non-conformance and CAPA activities; ensuring appropriate training of team as required. Enhance and develop Quality Management System activities associated with the release of CMO product, integrating as appropriate into central activities. Integrate with the QEHS and Compliance group on audit activities ensuring an adequate program executing audits as required. Ensure appropriate maintenance offiling of CMO related documents. Implement and ensure correct usage of appropriate Database(s) for the support CMO activities. Coordinate and supportthe control of Product Manufacturing activities. Undertake tasks as assigned by line Manager. Essential Criteria: Primary Qualification in Science, Engineering or related discipline. Quality Management experience 3 – 5 years minimum preferably in a medical devices company. Experience working in a GMP environment. Regulatory experience desirable. Apply for this job now or get in touch with Rena on 01 4690901. Matrix Recruitment Group is committed to providing a professional service where all CVs are kept confidential and will not be submitted to any clients without candidate’s knowledge or consent. This job originally appeared on RecruitIreland.com.

2386 days ago