Medical Device Quality Assurance Role
We are seeking a highly skilled and experienced professional to support the development, implementation, and maintenance of quality systems within our Medical Device organization in Limerick.
This role is ideal for an individual with a strong background in quality assurance, regulatory compliance, and product validation.
Main Responsibilities:
* Support Operations, Engineering, and Information Management teams in building quality into products and ensuring compliance with relevant regulations.
* Collaborate with cross-functional teams to develop and execute validation activities for new equipment, products, or system upgrades.
* Investigate and resolve complaints in a timely and efficient manner.
* Design and develop validation documentation to support business continuity, process improvement, and new product introductions.
* Cordinate the change control process to ensure timely approval of supporting documentation.
* Contribute to minimizing environmental and health & safety impacts through responsible work practices.
Requirements:
* Demonstrated expertise in relevant regulatory standards, including FDA Quality System regulations and ISO 13485, applicable to Class III medical devices sold globally.
Salary: €60,000 - €80,000 per annum, dependent on experience.