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:
Manage inspections at all stages, in-process, in-coming and final inspections, as needed
Manage accurate mechanical, physical and visual inspection when required as per specifications utilizing various measuring equipment (i.e.: calipers, micrometers, tensile tester, etc.)
Have the ability to read and understand product drawings and product specifications.
Have the ability to write product, component and process specifications.
Manage calibration and equipment maintenance requirements.
Work with production personnel to maintain quality of product.
Conduct various tests and quality checks on finished products.
Manage and conduct Environmental Monitoring requirements.
Customer Complaint Handling and determination of regulatory reporting.
Facilitate Corrective/ Preventive Actions, including root cause analysis, determination of required actions, and effectiveness of the actions taken.
Evaluation of Nonconforming Material for in house product and those originated from supplier product and services.
Maintain Supplier Evaluation File, including supplier audits (assessment surveys and on site audits), and re-evaluation as per required schedule.
Engineering Change Control evaluation and approval in accordance with regulatory requirements and standards.
Facilitate annual Management Review and Post Market Surveillance
Host ISO 13485, FDA, and Customer Audits of Quality Management System
Experience with any of the following areas is a plus: Design Control, Risk Analysis, Biocompatibility, Sterilization (EO and GAMMA) and MDD requirements.
Internal Number: N/A
About VLV Associates, Inc.
VLV Associates, Inc., is a privately owned company with over 35 years of service to the Medical Device Community. Our core business is in Medical Device Development, Manufacturing & Contract Packaging. We are an ISO 13485 certified company and we are FDA registered.
Our areas of expertise include product development, pilot production and design control.