A global healthcare solutions company committed to improving the lives of people are seeking a Senior Quality Engineer (Validations) to join their business on a contract basis for 18 months.
- 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 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.
- Provide on-going communication, information transfer and record keeping in support of business and core-team objectives and metrics.
What you need to have
- My client is 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.
Please get in touch to find out more information and have a confidential discussion
091 706 718