Quality Manager

2 days ago

Plano, United States Cobalt Product Solutions Full time

Reporting to ownership, the Quality Manager is tasked with immersing into the pre-existing and successful QMS while educating and influencing the engineering and manufacturing processes and teams (all finished products) to meet the expectations and demands of our customers. The Quality Manager supervises the Quality Control Technician while approaching the role with an analytical and introspective mindset remaining curious about how Quality could best excel our business objectives. 


Responsibilities

  • 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.
  • Recommend best practices or changes to management with confidence while being able to remain collaborative and understanding.
  • 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.
  • 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.
  • 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 specifically within an engineering, manufacturing, and/or product development setting
  • Three+ years of Quality experience
  • One+ year of experience leading audits
  • Ability to read and understand CAD drawings
  • 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


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