Quality Manager Location: will sit remote and at various site locations across the US and Europe The Quality Manager will provide medical device Quality Assurance technical expertise by participating in the day-to-day operation of the Department as it relates to the design and manufacture of medical devices. The candidate will manage the quality program with specific emphasis on Quality Systems, Verifications and Validations, FDA and ISO Audits, Vendor Management, CAPA's, Complaint Handling, and New Product Introduction. Ensures compliance to FDA Quality System Regulations and ISO13485 standards for all quality system processes and procedures. Directs Quality Assurance and Quality Engineering activities to foster a culture of continuous improvement. Duties and Responsibilities Manage and conduct all activities related to regulatory affairs and quality assurance in accordance with company policies, procedures, government laws and regulations and with a vision for driving quality excellence throughout the organization. New Products Introduction and Engineering Changes Assure regulatory and quality issues are addressed in support of new product development projects. Ensure a robust quality process related to validation and engineering changes. Attend new product Design Review meetings, review and/or approve labeling, IFU's, OEM contracts, FMEA, ECO's, design inputs, and overall compliance of project files as appropriate. Corrective and Preventive Action (CAPA) Oversee the development, implementation, updates and maintenance of the CAPA system (electronic and process) to ensure compliance with QSR, ISO and CMDR as well as additional local, state and federal standards and requirements. Provide direction and support for the CAPA process to ensure effective root cause corrective action is implemented to address nonconformance. Provide guidance and support to direct reports who are responsible for managing CAPAs. Interface with all levels of management, functional areas and customers as they relate to CAPAs and the CAPA process. Complaint Handling Oversee the world wide complaint handling system. Ensure robust execution of the complaint systems, MDR's (medical device (vigilance) reporting), internal documents and procedures in accordance with established by regulation/procedures. Qualifications: BS in a Science or Engineering or related discipline is required. A working knowledge of QSR/ISO requirements is preferred, along with a strong working knowledge of quality assurance and Manufacturing principles and practices. Travel: National & International travel required; anywhere from 40-80% Valid Passport Required #LI-JW1