Vantedge Medical · 11 hours ago
Quality Manager
Vantedge Medical is a leading metals-based med-tech solutions partner focused on advancing technology in manufacturing. The Quality Manager will oversee Quality Systems, Engineering, and Control for the Vander-Bend Sheet Metal Manufacturing business, ensuring product quality and compliance while driving continual improvement efforts.
ManufacturingMedicalMedical Device
Responsibilities
Manage the Quality Engineering group, direct QEs to improve processes and collaborate with other departments. Use statistical techniques to detect negative trends and identify opportunities for improvement
Manage the Quality Control group, direct inspectors to detect and resolve product quality issues on the production floor
Develop department inspection capabilities and efficiencies
Be VOC (Voice of Customer) in internal communications
Advise customers of metal processing capabilities for a successful realization of customers’ needs
Review and revise work orders, and identification of inspection checks
Create and/or review operating procedures, quality procedures and manufacturing practices as needed
Initiate/attend meetings with customers for continuous product/process improvement/cost reductions
Manage customer returns/complaints, non-conforming product/defective material, including MRB. Oversee the necessary steps to disposition and initiate corrective action when warranted
Work with all departments to ensure they have a true understanding of manufacturing quality and its application
Under the guidance of the Vice President of Quality, maintain compliance to ISO 13485 (including ISO 14971, Application of risk management to medical devices) and ISO 9001 standards
Undertake any additional responsibilities needed to improve quality and compliance
Qualification
Required
10 years in Metal Manufacturing (machining, forming, punching, welding, etc.) or similar industrial sector
5 years of progressive experience in Inspection and quality
5 Years of experience with people management
Familiar with QA/QC systems
knowledge of the ISO 9001 and 13485 Quality Management System, its implementation, and the creation of operating procedures and work instructions
General Inspection knowledge, including design of fixtures, inspection tools, methodology, mechanical design, metrology
Strong background in manufacturing including but not limited to machining, sheet metal, plating, painting
Possesses good computer skills
Company
Vantedge Medical
Vantedge Medical offers medical equipment manufacturing services.