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Supplier Quality Engineer, Caesare, Israel

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Engineering
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190004OX Requisition #
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< Supplier Quality Engineer >


Careers that Change Lives

In this exciting role as a Supplier Quality Engineer you will 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

 
  • Supports contract manufacturers and supplier quality activities and monitors production and compliance key process indicators.
  • Performs supplier audits and monitors findings closure.
  • Handles Supplier Corrective Action with supplier and monitors execution.
  • Supports new product introduction activities including 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.
  • 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
 

Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.



Must Haves
  • Bachelor degree in mechanical, electrical or similar engineering disiplines .
  • 5+ Years of Quality Assurance experience in Medical device or other regulated industry.
  • Understyanding of of applicable standards and regulations such as ISO 13485:2016 and 21 CFR 820.
  • Understanding of process validation principles, including experience with master validation plans, 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.
  • 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 Haves
  • Certified Quality Engineer (CQE) or other similar Quality/Reilibility certifications
  • 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 including Six Sigma, Lean Sigma.

 
 

Your Answer

Is this the position you were waiting for? Then please apply directly via the apply button!

About Medtronic

Mazor Robotics, Ltd., a Medtronic company.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of  what technology, therapies and services can do to help alleviate pain, restore health and extend life.

We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.

Let’s work together to address universal healthcare needs and improve patients’ lives.Help us shape the

future.
 

Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.


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