Our client a medical device company in Galway is hiring a Senior Quality Engineer for their site on a contractual basis.
At our Process Validation Department, we focus on providing process validation support during the full lifecycle of the product. From initial development of new products to line transfers to ongoing support when products have been commercialised we ensure that the performance and safety of the devices we support is maintained through the product lifecycle.
- You will lead the validation requirements for a product transfer to the Galway site providing input to process development and process validation.
- You will work as part of a cross-functional team, providing expert Quality Engineering technical direction and input to qualification and validation activities in conjunction with Engineering and extended QA teams.
- 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 and quality leadership.
- 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.
- Lead or support root cause investigations; drive problem solving efforts for quality issues.
- Provide on-going communication, information transfer and record keeping in support of business and core-team objectives and metrics.
The Ideal Candidate:
- 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 5 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 or software validation requirements an advantage.
- You are a good communicator and fluent in English, both in writing and speaking.
For further information on this Senior Quality Engineer role in Galway please contact Orla Crowley on 086 0449473 / Talent@hero.ie
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