We are recruiting for an excellent opportunity on behalf of our client, a leading medical device company based in Galway. The successful candidate will support the validation requirements for a product transfer to the Galway site providing input to process development and process validation.
Main Duties and Responsibilities:
* Author and support (input and critical review) of qualification/validation protocols/reports.
* Support the introduction/implementation of process/material changes to the manufacturing operation. You will assess the impact on process validation for these changes.
* Function effectively as part of cross functional teams; develop strong partnering relationships within these groups and provide constructive feedback.
* Understand product construction, features and uses at a highly competent level to contribute to decision making process on product acceptance standards within their scope of responsibility. Support the manufacturing line for the product during production.
* Lead or support root cause investigations; drive problem solving efforts for quality issues.
- Minimum of a bachelor's degree (Level 8 NFQ) in a relevant technical discipline (e.g., Engineering, Science)
- Minimum of 2 years relevant experience is desirable.
- Dynamic team player, who can work effectively and proactively on cross-functional teams.
- Drives accountability, thinks critically and has the ability to make sound decisions.
- Initiates and leads change, collaborates and creates alignment
- Knowledge of regulatory requirements and guidelines including 21 CFR part 820, MDR and ISO 13485 requirements is necessary.
- Knowledge of statistical requirements is necessary.
- Excellent communicator who is fluent in both spoken and written English.