SUMMARY:
The Director of Quality Assurance and Regulatory Affairs ensures continued regulatory conformity to FDA 21CFR820, ISO13485, ISO14971, and EU Medical Device Regulation (EUMDR). This position reports to the US CEO and indirectly to the Group Director of Quality Management and Regulatory Affairs.
This role encompasses a wide range of responsibilities, including the development and implementation of quality system procedures, training associates on updated procedures, overseeing the Corrective and Preventive Action process (CAPA), evaluating product and process non-conformances, and providing support to production and inspection teams in addressing quality-related challenges.
The director demonstrates excellence in cross-functional collaboration and effectively collaborates with teams at all organizational levels. Together, we are committed to upholding the highest standards of product quality and regulatory compliance.
ESSENTIAL FUNCTIONS:
KNOWLEDGE, SKILLS, AND ABILITIES:
For more information on this role contact Whitney Forbes at wforbes@gatewayrecruiting.com...
Apply For This JobJob responsibilities include, but are not limited to: Lighting, power, and special electrical systems designed for buildings Energy analysis Building...
Apply For This JobFor more information on this role contact Whitney Forbes at wforbes@gatewayrecruiting.com...
Apply For This JobJob Summary: The Field Diagnostics Tools & Systems Engineering team is seeking candidates with solid Software Quality Assurance experience to...
Apply For This JobJob Summary: This role will supervise and coordinate daily operation of production shift with responsibility for achieving quality and cost...
Apply For This JobThis position involves mechanical engineering, as well as project management and business development. Job Responsibilities: Mechanical Engineering: HVAC, plumbing, and...
Apply For This Job