Our client a Major Multinational here in Galway we are seeking applications from a suitably qualified and experienced Senior Quality Engineer – Process Validation.
- 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.
- Manage other process validation engineers as required.
- 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 the 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 ongoing communication, information transfer, and record keeping in support of business and core-team objectives and metrics.
- We are looking for a person qualified to a 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.
- Experience working in the medical device or other regulated industry.
- Experience of process validation activities in medical device or other regulated industry.
- Be focused on patient and customer, set high standards and instill operational excellence.
- Dynamic team player and 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.
- Good communicator and fluent in English, both in writing and speaking.
- Good organizational, presentation, and project management skills are desirable.
For more information or a confidential discussion about this role please contact Michelle Mc Inerney.
091 706 717