• Develop, establish and maintain quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and regulatory guidelines to ensure customer satisfaction.
• Support the Company’s short-term and long-range quality and regulatory plans
• Support the Company’s corporate culture which accepts nothing less than the delivery of quality products and services to every customer, consistently.
• Develop and maintain effective internal relationships to assess procedures and coordinate operations.
• Interact with executive-level management to report on the performance of the quality system.
• Assure effective systems, validations, and controls are established and maintained with new products from development to operational environment.
• Maintain system to assure corrective and preventive measures are systematically implemented, monitored, and controlled.
• Maintain a system to ensure potential customer complaints are received, evaluated, and, where necessary, investigated in a timely and uniform manner.
• Oversight of ongoing Quality Assurance education to all company employees.
• Provide guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance.
• Lead company through regulatory inspections/audits
• Attend education events hosted by professional organizations and practitioners to stay abreast with current Best Practices.
• Serve as the Person Responsible for Regulatory Compliance for Europe. The person responsible for regulatory compliance shall at least be responsible for ensuring that:
(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
(c) the post-market surveillance obligations are complied with.