Our client is a global medical device healthcare solutions company who are committed to improving lives through medical technologies, services, and solutions. They operate across 350 facilities in 150 countries, with an innovative portfolio of over 46,000 patents.
There is an exciting opening for a Senior Quality Engineer - Process Validation to join the Process Validation Department. This area focusses on providing process validation support during the full lifecycle of the product. From the initial development of new products to line transfers to ongoing support when products have been commercialised, this team and department ensure that the performance and safety of all device products are maintained through the product lifecycle.
- 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.
- 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.
- Bachelor's degree in a relevant technical discipline (e.g. Engineering, Science).
- Minimum of 5 years relevant experience in Medical Devices - knowledge of regulatory requirements and guidelines including 21 CFR parts 210, 211, 21 CFR part 820, ICH requirements and ISO 13485 requirements is necessary.
- Dynamic team player that 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.
To discover more about this opportunity, apply now or contact Helena Boyle at HRM on +353 1 6321870 or 0873360953 for a confidential discussion.