Job Title: Director Quality Assurance
A world-leading medical technology company is seeking a motivated Director of Quality Assurance to oversee quality assurance efforts in support of the Quality Management and Oversight Systems, reflecting core values of innovation, evidence, integrity, teamwork, respect, and patient safety.
Salary:
$120,000 - $180,000 per year
Job Description
The Director, Quality Assurance will lead the development, establishment, and maintenance of quality assurance programs, policies, processes, procedures, training materials, and controls enhancing product performance and the company's capability to demonstrate conformance to established standards and agency regulations.
* Provide overall Quality Assurance leadership, including setting the vision and direction of the Global Quality Assurance Team
* Direct the activities of the Global Quality Assurance Team
* In collaboration with VP Quality and key stakeholders align annually on workforce planning, budgeting, and talent management
* Architecture and maintenance of the Quality Management System
* Definition and execution of Quality Assurance activities for oversight and monitoring of products and services
* Definition and execution of superior Internal and External Audit management processes
* Definition and execution of superior product surveillance activities, including regular and informative reporting on field performance of products
* Offer expert guidance and direction of the Quality Assurance Body-of-Knowledge
* Proactively identify opportunities to apply, continuously improve, and redefine quality assurance systems and controls for all divisional product-related processes in accordance with applicable internal, domestic, and international quality regulations
* Collaborative leadership with all divisional sites to drive proactive quality system improvements
Requirements:
* BSc in Bioscience, Biomedical Engineering, Engineering, or equivalent related field
* Demonstrated expert-level knowledge of Medical Device Quality Assurance practices, policies, and methods in support of Class II or III medical devices
* Selection and definition experience with Electronic Quality Management Systems such as MasterControl, Trackwise, EtQ, or others for documentation, CAPA, auditing Quality System elements
* Deep knowledge of and demonstrated external audit success with International and Domestic regulators, agencies, and Notified Bodies
* Experience in assessing people and building industry-leading people and teams