Sr. Director Quality Assurance

Overview: The Sr.

Director of Quality Assurance, functioning as Head of Quality, is responsible for providing quality leadership and oversight as global business process owner to establish and maintain a quality system to ensure compliant and effective processes in support of product design and development, as well as sustaining engineering and quality system support of the Company’s products.

The Sr.

Director of Quality serves as the Company’s Management Representative and jointly serves as the Person Responsible for Regulatory Compliance (PRRC) in conjunction with the head of Regulatory Affairs.

Responsibilities: 


* Direct the establishment and maintenance of quality system policies and procedures to ensure that products and processes meet applicable domestic and international medical device quality system regulations, standards, and specifications.

Maintain awareness of new and revised standards and regulations and execute quality planning activities to ensure compliance with them.

Partner with functional groups within the Company to ensure the Quality System can be effectively implemented to meet business objectives


* Develop credibility and work closely with cross functional teams to elevate implementation of the Quality Policy, foster a culture of quality, efficiency, and excellence ensuring that quality and compliance are integrated into the day-to-day operations and long-term Quality strategy, and instill a Quality vision across the Company


* As management representative, lead the planning and delivery of periodic Management Review activities to communicate to and collaborate with senior management to ensure the effectiveness of the quality management system, identify and act on any need for improvement, and ensure the promotion of awareness of applicable regulatory requirements and QMS requirements throughout the organization


* Execute the function of the Person Responsible for Regulatory Compliance (PRRC) as defined in the EU Medical Device Regulations, together with the head of Regulatory Affairs


* Lead and promote quality and regulatory compliance through effective implementation of a proactive internal audit process.

Lead preparations for regulatory inspections, host inspections, and maintain a state of inspection readiness


* Oversee processes to receive, evaluate and respond to customer complaints, including escalation of reportable events, analysis of trends, determination of the need for corrective and preventive action, and feedback to the field as necessary


* Oversee the Company corrective and preventive action process and ensure its effectiveness and integration with other elements of the Quality Management System


* Partner with R&D, Manufacturing Engineering, and Supply Chain Management to drive continuous improvement in process controls in the management of and communication with contract manufacturers to ensure consistent product quality and quality system compliance in the Su...