| Sigvaris Group is currently looking for a Senior Manager Quality Assurance & Regulatory to join our team. As a leading compression solution provider, we are not just a company that manufactures products. We are a global team on a mission to help people feel their best. The Senior Manger of Quality Assurance & Regulatory is responsible for maintaining and ensuring the company's quality management system complies with the FDA, ISO-13485, medical device regulatory standards, and managing the departmental personnel at two facilities: Holland, MI and Peachtree City, GA. The position also has the responsibility to identify and implement solutions for improvements in safety, quality, and in other assigned areas. Responsibilities * Act as a point of contact for all regulatory communication in the company, including incident reports, audits, and registrations. * Ensure the Quality Management System complies with FDA, ISO-13485, and other international medical device regulatory standards. * Serve as Lead Auditor; manage all internal audits; prepare for all external audits; address non-compliance issues from both internal and external audits. * Responsible for managing product failures and takes appropriate actions. * Maintain high standard of customer service to include investigation and resolution of quality complaints. * Utilize statistical data to support the qualification of new products. * Oversee calibration and testing program. * Develop Quality metrics and goals; lead efforts related to the company's quality vision. * Develop Quality related training programs. * Responsible for the overall supervision, training and development, motivation, coordination, and evaluation of the Quality Department staff. *Proactively coach and motivate employees in the department. * Effectively address employee concerns, disciplinary actions, and resolve problems. * Ensures all employees in the department know how they are doing compared to their performance standards. * Ensure all employees in the department have the skills and knowledge to do their jobs, or there is a plan to obtain them. * Ensure all employees in the department receive an interim and annual performance review. * Ensure there is evidence that an ongoing informal recognition system is being used. * Maintain a positive and professional working relationship with all departments and/or current and vendors using a "partnership" approach. Generate effective communication, good relations and a positive service-oriented image with coworkers promoting courtesy, objectivity, and fairness. * Follow established procedures and guidelines that ensure compliance with Sigvaris policies, industry standards, industry standards, ISO 13485 standards, and Federal, State, and local laws. * Support the Sigvaris Quality System and Quality Policy by following work instructions and creating and maintaining records to meet all internal and external requirements. * Demonstrate effective communication methods. * Ensure Quality Department and/or appropriate management staff are kept informed of developments affecting their functions. * Respond quickly to all oral and written communications. * Maintain and encourage open lines of communication with both internal and external customers. * Checks and responds to voice mail messages in a timely manner. * Accurately and legibly presents written data to affected internal/external customer. * Accurately performs any other duties as assigned to ensure an efficient workflow. | 
