QA/Validation Engineer

ICDS Recruitment

Louth

QA/Validation Engineer – Co. Louth. FIXED TERM CONTRACT - 12 MONTHS. Operating as part of the Quality Team providing leadership, knowledge and expertise in the area of quality and assurance for Medical Device Manufacture organisation whilst also supporting other activities in relation to Quality Engineering and Quality Systems. RESPONSIBILITIES: Plan, document and implement process validations in accordance with best industry standards and corporate templates. Support Process Engineers in validation and change management activities. Generate IQ, OQ, & PQ protocols including equipment qualification and software validation where relevant. Act as plant representative during Design Transfer and Design Review meetings with Unit QA & R&D. Document and Manage deviations recorded in the validation lifecycle execution. Co-ordinate execution of validation protocols, including sampling and inspection/testing of validation components. Ensure compliance of the validation documents with with all applicable medical device regulations as well as Corporate Quality Plan. Preparation of validation reports for design review meetings. Preparation and presentation of validation reports to local Management Team. Active participation in local and external validation project team meetings. Contribute to plant maintaining ongoing compliance with ISO13485. Act as Subject Matter Expert for Notified Body/Regulatory Audits. Support Quality Engineering/Continuous Improvement activities as required. Ensure adherence to all regulatory requirements. Promotion of Quality Awareness and cGMP within the Plant. SOP writing and maintenance. EDUCATIONAL REQUIREMENTS: Degree Qualified in Engineering, Science or Quality related discipline. RELEVANT EXPERIENCE: Experience of equipment, software and process validation. Experienced in working to project deadlines. Management of validation activities to ensure adherence to project schedule. Ability to work with process engineers on protocol development. Understanding of the validation lifecycle. Ability to be a team player in cross functional teams including QA, Engineering, Project Management, Regulatory Affairs and Operations. 4+ Years relevant work experience in a regulated medical device or pharmaceutical environment- with exposure to ISO 13485 & 21CFR 820. Strong Understanding of GMP. This job originally appeared on RecruitIreland.com.

2589 days ago