Quality Engineer

07 Apr 2021
28 Apr 2021
Megan Power
Job Type
Contract Type: Fixed Term 12 months

Location: Galway- initially work from home

Start date: ASAP

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

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