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Supplier Quality Engineer - Caesarea, Israel

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Engineering
📅
20000BPH Requisition #

Careers that Change Lives


In this exciting role as a Supplier Quality Engineer you will the lead supplier quality engineering activities supporting production and medical device release processes. This positions  Partners with QA, Engineering, Supply Chain and supplier’s functions to ensure quality and compliance of manufactured products.



A Day in the Life

Responsibilities may include the following and other duties may be assigned

 
  • Work with development engineering and manufacturing engineering to translate design requirements to manufacturing requirements.
  • Supports contract manufacturers and supplier quality activities and monitors production and compliance key process indicators.
  • Performs supplier audits and monitors findings closure.
  • Work closely with Development Engineering to assure appropriate requirement definitions are established.
  • Collaborates with mechanical engineering and manufacturing functions to ensure supplier is capable of producing and inspecting components.
  • Handles Supplier Corrective Action with supplier and monitors execution.
  • Supports new product introduction activities by collaborating with core team members to execute supplier integration, process, equipment, SW and environment validations, production risk management, control plans, component qualification and staff training.
  • Utilizes advance statistical tools and practices to analyze and improve production and product performance.
  • Be a key contributor in problem solving efforts to identify and resolve challenging quality issues to ensure production of safe and effective medical devices.
  • Represents supplier quality in internal and external audits.
  • Participates in Material Review Boards and communicates back to supplier.
  • Supports incoming inspection specification development.
  • Provide onsite QA support to contract manufacturers.
  • Communicates Engineering Changes Notices (ECN) to suppliers and monitors implementation
.
Must Have
  • Bachelor degree in statistics, mechanical, electrical or similar engineering disiplines .
  • 2+ Years of Quality Assurance experience in Medical device or other regulated industry.
  • Understanding of of applicable standards and regulations such as ISO 13485:2016 and 21 CFR 820.
  • Understanding of process validation principles, including experience with, installation qualifications, operational qualifications, process qualifications, and test method validations.
  • Experience in application of risk management techniques in supporting of design, production and post production activities.
  • Understanding of various manufacturing processes
  • Strong knowledge in CAPA, NCMR, RMA, Labeling, Rework and Batch release processes.
  • Ability to work effectively in a team environment with a diverse group of people.
  • Ability to effectively solve problems.
  • Strong technical understanding.
  • Fluent in English and Hebrew.
 
 
Nice to Have
  • ISO 13485:2016 Certified lead auditor
  • Certified Quality Engineer (CQE) or other similar Quality/Reilibility certifications
  • Lean Six Sigma green/black belt
  • Experience in utilization of statistical techniques such design of experiments, hypothesis testing, SPC, etc. as part of Quality Engineering discipline.
  • Supplier Quality Engineering experience.
  • Working knowledge of process improvement skills.

 

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