Supply Quality Engineer
Abbott
Alajuela, Costa Rica
hace 19 horas

Essential Functions :

  • Leads in the development, maintenance and improvement of supplier quality program policies, procedures and forms.
  • May supervise other Supplier Quality Technicians and or receiving inspection personnel.
  • Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements.
  • Leads multifunctional teams in completing program directed or continuous improvement activities.
  • Reviews and approves all supplied product drawings and component quality plans.
  • Manages development of supplied product inspection procedures and first article requirements.
  • Provides engineering guidance to Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures.
  • Assesses supplier capabilities through direct visits, technical discussions, directed testing and quality system audits.
  • Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests and technical discussions.
  • Participates and provides engineering ownership for all supplied product Non-Conforming Material Reviews.
  • Applies sound engineering analysis and judgement to reduce the need for inspection in accordance to program policies.
  • Works with Manufacturing engineering to assess and address purchased product issues.
  • Participate in or lead teams in supporting Supplier Assurance program requirements (e.g., represent the Supplier Assurance function as a Core Team Member.)
  • Qualifications :

  • Bachelor’s degree in engineering or Technical Field.
  • Advance command of English
  • Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
  • 3+ years experience, with preferably 2+ years in quality engineering roles.
  • Statistical / data analysis and report writing skills.
  • Demonstrated use of Quality tools / methodologies, such as : (Root Cause Analysis, Fishbone, Is / Is Not, etc.), Six Sigma or Process Control & Monitoring (SPC).
  • Knowledge of FDA, GMP, QSR CFR 21 Part 820 and ISO 13485.
  • Technical writing experience.
  • Quality Auditor training for ISO 13485 or 9001
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