Responsibilities:
* As part of a cross-functional team, provide Quality Engineering technical direction/input to the product development process.
* Provide expert QE technical direction/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/materials 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.
Experience:
* They 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 parts 210, 211, 21 CFR part 820, ICH requirements and ISO 13485 requirements is necessary.
* Knowledge of combination products, statistical requirements or software validation requirements an advantage.
* You are a good communicator and fluent in English, both in writing and speaking.
If you would like to hear a little bit more about it, please email me your CV to [email protected] or apply in the link below.