Our client, a medical device company in Leitrim are currently looking to recruit a QA Validation Engineer for their site.
The QA Validation Engineer will join an existing Quality department and will play a key role in reviewing and approving of all validation protocols to ensure compliance with current regulatory expectations.
- Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485 & MDD 93/42/EEC.
- Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO 13845. Generation of Product Technical Files & associated studies in accordance with MDD 93/42/EEC when appropriate.
- Completion of Validation Programme ? Risk Analysis, VMP, IQ?s, OQ?s, PQ?s as required according to procedure QAP 030 and other related procedures
- Provision of support to all departments to ensure that products manufactured meet customer requirements
- Review and Release of batch paperwork for Product release.
- Maintenance of the Customer Complaint investigation process, MEDDEV 93/42/EEC vigilance requirements and assisting in product recalls & corrective/ preventive action programme.
- Participation in routine Failure Investigation & process trouble-shooting
- Quality System Certification, ideally 2-3 yrs. previous experience.
- Strong Process Validation and extrusion experience and skills
- Excellent problem solving and troubleshooting skills and communication skills.
For further information on this Validation Engineer role in Leitrim please contact Cliona O?Malley on 091730022 / firstname.lastname@example.org
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