At out client Process Validation Department, they focus on providing process validation support during the full lifecycle of the product. From initial development of new products to ongoing support when products have been commercialized we ensure that the performance and safety of the devices we support is maintained through the product lifecycle.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 firstname.lastname@example.org or apply in the link below.