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.)
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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