Quality Assurance Director is responsible for the implementation of policies and procedures to ensure adherence to production quality standards. Monitors and audits process, material, and product testing against established standards and conducts a continuous analysis of quality defects and deviations. Being a Quality Assurance Director identifies deficiencies or gaps in testing activities and develops solutions to ensure adequate and robust quality processes. Optimizes processes to comply with existing and new regulatory requirements. Additionally, Quality Assurance Director typically requires a bachelor's degree. Typically reports to a director. The Quality Assurance Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Quality Assurance Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
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.
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KNOWLEDGE, SKILLS, AND ABILITIES:
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