Quality Engineer – Process Validation II
Job ID: JOB-11450
Title: Quality Engineer – Process Validation II
Duration: 12 months FTC
Location: Parkmore / WFH Start
Our client is a well-known Galway based multinational with sites across Ireland with an opportunity for an experienced Quality Engineer – Process Validation to join a high performing team! As the Quality Engineer – Process Validation, you will support the validation requirements for a product transfer to the Galway site providing input to process development and process validation.
Key Responsibilities: (Not limited to the below)
- Supporting the validation requirements for a product transfer to the Galway site providing input to process development and process validation.
- 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.
- We are looking for a person qualified to Minimum of a Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Science) and desirably with a minimum of 2 years relevant experience.
- You are a dynamic team player, can work effectively and proactively on cross-functional teams.
- Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability and Thinks Critically and Makes Sound Decisions.
- Knowledge of regulatory requirements and guidelines including 21 CFR part 820, MDR and ISO 13485 requirements is necessary.
- Knowledge of statistical requirements is necessary.
- You are a good communicator and fluent in English, both in writing and speaking.
For further information on this role please contact Shane Connolly on 0872197421 or firstname.lastname@example.org
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