Quality Manager

Reporting to ownership, the Quality Manager is tasked with the obligation to ensure Cobalt’s QMS is adhered to the engineering and production processes and all finished products meet the expectations and demands of our customers. The Quality Manager supervises the department and Quality Control Technician while executing attention to detail and drives results from an analytical approach.

Responsibilities

• Oversee the inspection and testing of incoming materials, subassemblies, and finished goods for quality assurance and design compliance using CAD, 2D drawings, and work instructions.
• Independently leads and manages internal and external audits.
• Manage quality inspectors and assembly techs for quality inspections and ensure proper records are kept.
• Maintain quality documentation for all incoming materials and finished goods, including inspection records, non-conforming product logs, and contracts of conformance.
• Alert management of any design deviations during inspection.
• Take ownership of the quality management system including ISO9001:2015

and ISO13485.

• Serve as a liaison with external parties on matters relating to the quality management system.
• Provide quality training for new hires as well as continuing education for staff.
• Ensure compliance in all areas making recommendations for improvements while implementing any corrective actions needed.
• Execute on the vision from management while conforming to and improving our system - develop QMS, SQA, etc. as needed.
• Be able to work in teams/collaboratively with others to create optimal solutions to support and grow the business while assisting other departments to train, develop, audit, etc.
• Work within a quality management system and properly communicate as needed - keeping coworkers and supervisors informed.
• Follow both verbal and written directives.
• Perform other assigned duties as needed.

Skills and Qualifications

• Three+ years of experience managing a QMS within a production setting
• Three+ years of managerial experience
• Ability to read and understand CAD drawings
• Three+ years of experience with standard inspection and measurement tools and equipment. i.e. micrometers, pin gauges, calipers, gauge blocks, and surface plates
• Knowledge and understanding of GD&T
• Strong knowledge of ISO9001:2015 and ISO13485
• Strong analytical mindset
• Internal auditor certification/willing to pursue certification
• Regulatory compliance experience within the medical device field not required, but a plus