The Sr. Supplier Quality Engineer role is responsible for maintaining the Quality and Operational performance of Visby’s suppliers to support device and reagents manufacturing. The role is a member of a multidisciplinary team that manages suppliers.

Together in a multidisciplinary team will drive supplier development and provide technical process improvements of quality and yield improvement, process control, cycle time reduction, risk analysis and reduction.

Essential Duties

  • Responsible for CAPA/8D validation at suppliers 
  • Gatekeeper for all activities regarding supplier complaints (SCAR)
  • Perform and support supplier for PPAP, change notices, and other supplier quality related activities
  • Drive supplier process capability through deployment of quality control (CpK, SPC)
  • Facilitate supplier generated change requests 
  • Facilitate supplier deviation requests
  • Conducts process readiness audits at supply base
  • Review and comment on component drawings, calculations, stack-ups, specifications, and other design inputs/outputs at launch of new drawings 
  • Promote process improvement and support innovation of supplied components and how they interact with internal processes
  • Responsible for collecting and maintaining lessons learned at supply base and ultimately, continual complaint reduction
  • Prepare reports by collecting, analyzing, and summarizing supplier data and making recommendations to management team and purchasing 
  • Facilitates communication between Visby Medical and suppliers
  • Responsible for suppliers adhering to Visby Medical standards/requirements 
  • Maintains a working knowledge of industry standards 
  • Ability to travel domestically and internationally
  • Supports serial production and product quality activities as needed 
  • Facilitate and monitor supplier trip reports and technical meeting minutes

Education and/or Experience

  • BS degree in electrical, mechanical, chemical, or industrial engineering, or related discipline a plus
  • Minimum of 5 years of management experience in Supplier Quality or Quality Engineering function
  • Experienced in supplier management, quality improvement & operational excellence in manufacturing environment
  • Experience in leading quality improvement projects across the supply chain preferred
  • In-depth knowledge of quality-tools especially PPAP, MSA, Process Capability and knowledge of measuring and test equipment
  • Lean 6S experience (e.g. DMAIC, SPC, FMEA, 8D), Black Belt certification preferred

Other Qualifications 

  • Excellent written and interpersonal communication skills

Physical Demands

  • Comfortable performing repetitive tasks and/or motions
  • Must be able to lift a minimum of 10 lbs

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