Quality Engineer

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Galway . This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

You will support 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.

Education & Experience

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.