A global healthcare leader is seeking a Quality Engineer | Validation to join their growing team in Donegal. This is an initial 6-month contract. The Quality Engineer (Validation) plays a pivotal role in implementing and maintaining the effectiveness of the Quality System.
Responsibilities
* Reviews and approves all validation deliverables for Equipment, Facilities, Utilities, Software, Spreadsheets, and Analytical validations at site.
* Develops and maintains Quality System procedures.
* Ensures the site delivers safe and effective products that meet customer needs while maintaining compliance.
* Maintains the quality and compliance status of associated quality records.
* Maintains the quality and compliance status of associated Procedures, work instructions, and training materials.
* Presents and communicates status, reports metrics, identifies trends, potential issues, improvement initiatives, as applicable.
* Participates in continuous improvement programs to implement improvements in manufacturing, quality, safety, and training systems.
Ideal Background
* Relevant third-level qualification in Engineering, Manufacturing, or Science preferred.
* Minimum 2 years of experience in Engineering, Manufacturing, or Scientific roles.
* Must have a minimum of 1-2 years of validation experience within manufacturing or Testing Laboratories with an emphasis on software and equipment validations.
* Must be a self-starter who can prioritize own work.
* Experience with Manufacturing Execution Systems is desirable.
* Experience with manufacturing Database is desirable.