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.
Work on New Product Development as part of a cross-functional team, provide Quality Engineering technical direction/input to process development.
· Provide expert QE technical direction/input to qualification and validation activities in conjunction with Design, Engineering and extended QA teams.
· Author and support (input and critical review) of qualification/validation protocols/reports.
· 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.
· Support the introduction/implementation of process/materials changes to the manufacturing operation. You will assess the impact on process validation for these changes.
· Provide on-going communication, information transfer and record keeping in support of business and core-team objectives and metrics.
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 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, Thinks Critically and Makes Sound Decisions.
· Knowledge of regulatory requirements and guidelines is an advantage.
· Knowledge of statistical requirements and software validation requirements is an advantage.
· You are a good communicator and fluent in English, both in writing and