Medical Device Quality Assurance Role
We are seeking a highly skilled and motivated individual to support the activities of Operations, Engineering, and Information Management in building product quality into our medical devices and ensuring compliance with pertinent regulations while achieving operational effectiveness.
Key Responsibilities:
* Collaborate with various departments to develop and execute validation activities for new equipment, products, or system upgrades.
* Investigate and resolve complaints in a timely manner.
* Design and develop validation documentation to support business continuity, process improvement, and new product introductions.
* Implement and coordinate the change control process to ensure timely approval of supporting documentation.
* Contribute to minimizing environmental and health & safety impacts of work activities.
Requirements:
* Strong knowledge of relevant regulatory standards (F.D.A. - Quality System regulations, ISO 13485) applicable to Class III medical device manufacturing for global markets.