- Reference: 46698
- Job Type: Permanent
- Location: Galway, Offaly, Westmeath
- Category: Science, Pharmaceutical & Food
This is a fantastic opportunity for an experienced QE to join this start up in their infancy stage, ideal for someone that is thinking of the next step on the career ladder with a vision to a senior position.
The successful Quality Engineer will support and development of the quality management system. Completion of internal audits, Supplier approval and auditing, Supporting on ISO 13485 and 21 CFR 820 audits, Daily monitoring of key processes and metrics, Be the primary contact between QA and Manufacturing, Management of the NCR / CAPA process.
Quality Engineer requirements:
- BS in Quality or other appropriate 4 Year Degree
- 5 years exp in Medical Device industry
- Extensive knowledge and understanding of US and international medical device regulations, standards and guidance documents.
- Experience in clean room qualification requirements.
- Experience in water system and qualification requirements.
- Knowledge of microbial test methods.
- Ability to communicate and to present reports & ideas.
- Knowledge of EO Sterilization
For more information or to apply please contact Tina Egan on firstname.lastname@example.org 09064 78104.
Please Note: Collins McNicholas will not forward your details to any company without your prior approval.
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