This innovator U.S multinational Healthcare organisation manufactures and distributes products used in diagnostic procedures and in the treatment of pain and related conditions. This includes the development, manufacture and distribution of specialty pharmaceuticals, active pharmaceutical ingredients, contrast products and radiopharmaceuticals – not to mention and extensive portfolio of medical devices. The company employs over 5000 staff globally with 47 locations around the world with net sales circa 4 Billion. Due to heavy expansion here in Ireland, a requirement for Quality Manager has arisen to be based at the organisations green field R&D/Pilot scale delivery device manufacturing plant.
- Provide technical expertise in product development projects, design reviews, verification, validation, serviceability, and manufacturability involving R&D and Sustaining Engineering.
- Collaborates on and approves Engineering Change Requests and Engineering Change Notices
- Supervises design quality team to ensure appropriate resource allocation, training, development, goal
- Chairs the device Change Control Board; Member on the Product Support Team; Assists Quality functional management with duties as needed.
- Ensures transfer of product development to manufacturing, service and field deployment.
- Support creation, implementation and training of procedures to govern product development including, but not limited to, design controls, risk management, verification, validation, review, and transfer.
- Participate and/or own development and implementation of corrective and preventive action plans to improve overall compliance and quality management system results.
- Ensures applicability of current quality policies, procedures and objectives by keeping informed of the latest updates/modifications related to FDA and ISO quality systems.
- BS/BA in Scientific or Engineering discipline
- 10 years’ experience in cGMP-regulated environment
- Working knowledge of Quality Engineering principles and device cGMP’s specifically related to design and development and risk management.
To learn more apply on line or call Shane Browne on +353 1 6321865.
Salary: On Application
Location: Dublin City Centre