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Sr Product Quality Engineer, Caesarea, Israel

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Engineering
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190009CH Requisition #
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Careers that Change Lives
In this exciting role as a Sr. Product Quality Engineer you will directly support the day-to-day release product activities at our Ceasarea facility. You will have the opportunity to drive a culture of continuous improvement by deploying sound engineering fundamentals to achieve quality objectives and ultimately yielding better patient outcomes. 

A Day in the Life

Responsibilities may include the following and other duties may be assigned

 
  • Collaborates with R&D, QA, Engineering and Manufacturing functions to ensure quality standards are in place.
  • Participates in and influences release product changes core teams
  • Takes an active role in leading, reviewing and approving design and manufacturing changes.
  • Performs and reviews change impact assessments to manufacturing and post market  characteristics.
  • In collaboration with Post Market Surveillance team, supports new product launch activities,  participates in the investigation, resolution, and communication of product issues.
  • Leads product quality investigations in support of CAPA, complaints and Non-conforming material processes.
  • Lead sterile product monitoring program incl. Bioburdenn, Dose audit and LAL tests.
  • Mentors cross functional teams in investigations and problem solving best practices.
  • Collect, analyze and interpret statistical data, performs analyses and provide reports as required.
  • Leads Quality Assurance and product quality improvements cross functional initiatives
Must Haves
  • Bachelor degree in mechanical or similar engineering disiplines .
  • 5+ Years of Quality Assurance experience in Medical device companies or other highly regulated industries.
  • Strong knowledge of applicable standards and regulations standards
  • Vast experience with design changes, change impact asseesment and design transfer activities.
  • Strong 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 (FMEA, FTA)  in supporting of design, production and post production activities
  • Strong understanding of product lifecycle process
  • Ability to work effectively in a team environment with a diverse group of people.
  • Fluent in English and Hebrew
 
Nice to Haves
  • Certified Quality Engineer (CQE) or other similar Quality/reilibility certifications
  • Six Sigma Black belt certification
  • Experience with medical device sterilization and reprocessing standards.
  • Experience in utilization of statistical techniques such design of experiments, hypothesis testing, SPC, etc. as part of Quality Engineering discipline.
  • EUMDR and MDSAP knowledge/experience
 

Your Answer

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

About Medtronic
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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