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Quality Engineer

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Ensure that the organization’s Quality management System conforms to customer, internal, ISO 9001:2015, ISO 13485:2016 and regulatory/legal requirements
  • Be the technical expert in the Electronic Quality Management System and modules that control relevant functions
  • Oversee process and product inspections that include deciding and implementing inspection methods, sampling plan and inspection equipment
  • Assist to quality meetings and management review meetings to report to top management technical data regarding the performance and effectiveness of the quality management system
  • Work with engineering and quality manager and lead quality/continuous improvement projects
  • Work closely with the customer and developing quality assurance plans for new customers and improving process efficiency for existing customers
  • Provide support in entering of RMAs, CAPA, monitoring of DCRs and Deviations, and PPM tracking
  • Assist in document control functions by creating new operating procedure, work instructions, forms etc.
  • Responsible for supporting Engineering and Manufacturing to resolve technical issues and implement corrective and preventive action (CAPA)
  • Maintain KPI’s as required by Quality Management System
  • Leading supplier / internal process improvement projects in an effort to increase the supplier/internal process capability of consistently meeting ISO and regulatory requirements. Projects may include: process analysis, value stream mapping, process capability and throughput analysis, DOE, 6‐Sigma, 5S and Kaizen events
  • Act as the Supplier Quality Representative and conduct all Supplier Quality Reviews.
  • Programming CMMs and other measurement gages to customer drawings
  • Assist maintenance department with external and internal calibration of critical measuring equipment
  • Manage, coordinate and assist teams for internal and external validation/verification of processes
  • Assist in audits which includes ISO 9001:2015, 13485:2016 Internal, External, supplier and Customer audits
  • Collaborate with external interested parties to improve Quality management system
  • Other duties as assigned

SUPERVISORY RESPONSIBILITIES

  • None

EDUCATION AND EXPERIENCE

  • Bachelors’ degree or higher in Engineering Management/Mechanical/Manufacturing/Industrial Engineering or related field with 2+ years’ experience
  • 2 years in Quality Engineering or related field in the industry preferred
  • Prior experience in GD&T and ability to read blueprint and drawings

KNOWLEDGE, SKILLS, AND ABILITIES

  • Lean Six sigma Green Belt certification or higher desired
  • Knowledge of GD&T and ISO 9001:2015, ISO 13495:2016 standards
  • Proficiency in precision measurement tools like Vision systems, 3D profilometers, optical microscopes etc.
  • Experience working in ISO Class 5 and Class 6 cleanroom environment
  • Knowledgeable of Control Plans, DOE, XFMEA, SPC, and other lean six sigma tools
  • Excellent verbal, technical writing, interpersonal and organizational skills required

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