VLV Associates, Inc. is a manufacturer and packager of Class I and Class II Medical Devices. VLV is seeking a Quality Manager to ensure our Quality Management System is established and maintained in accordance with ISO 13485 and FDA Quality System Regulation requirements.
Duties to include, monitoring/maintaining the quality system requirements as per the Company Quality Assurance Procedures, management of quality inspectors, routine product and process inspections, and demonstrating QMS compliance through ISO, FDA, Customer, and 3rd party Internal Audits. Must be detail oriented, flexible, and have ability to prioritize multiple tasks based on customer and company needs.
Key duties/responsibilities of Quality Manager:
Experience with any of the following areas is a plus: Design Control, Risk Analysis, Biocompatibility, Sterilization (EO and GAMMA) and MDD requirements.