Quality Engineer - Medical Devices - Galway
A Medical Devices company in Galway is looking for a Quality Engineer to provide quality support to their design team. This is a chance for your work to make a real difference in the quality of peoples' lives.
This challenging position will require an ability to work with minimum supervision, pursue continuous improvement and ensure compliance to the Company's Medical Quality System
Key Job Responsibilities:
* Overall responsibility for production GMP standards and compliance.
* Investigation of root cause and following through on effective corrective actions to prevent re-occurrence for customer and internal quality issues.
* Establishing inspection standards, plans, frequencies and test methods.
* Establishing and maintaining FMEA's.
* Preparing and updating Operations procedures and associated documentation.
* Reporting area of responsibility metrics.
* Supporting customer and surveillance accreditation audits.
* The quality engineer will perform an active role in quality planning and new product introduction from a quality perspective.
* Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements.
* Degree in Quality or Degree in Science / Engineering.
* Experience within a similar role as quality engineer.
* 5+yrs industry experience in a medical device-manufacturing or pharmaceutical environment.
* Working knowledge of FDA and ISO Quality systems for Medical device companies.
* New product introduction and manufacturing process transfer experience would be a distinct advantage.
* Quality experience in component and device manufacturing desirable.
* Excellent written and oral communication skills essential.
Please send your CV to firstname.lastname@example.org or call Christy on +353 (0)87 9473404