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Design Control Lead Engineer

As Design Control Lead Engineer you will be leading product quality in R&D, supporting regulatory submissions and ensuring that regulatory requirements are met.

If you have the skills and experience, we’d like to hear from you.

Location:

Ramat Gan/Haifa, Israel (On-site)

Employment:

Full time

In this role you can expect to:

  • Support R&D design processes.
  • Participate in design reviews, supporting the R&D teams to ensure that the relevant regulatory standards are met.
  • Lead product risk management.
  • Participate in design change processes.
  • Participate in design transfer processes [transfer from R&D to production].
  • Support verification and validation processes.
  • Establish quality planning for product development and determine regulatory requirements for the product.
  • Be part of the core project team and support product usability processes.
  • Examine design defects as part of the design process.
  • Support the management of design files and regulatory submission files for submission to relevant authorities.
  • Lead corrective and preventive actions [CAPA] and trend analysis for processes.
  • Follow the company's quality objectives.
  • Prepare for internal and external audits.

To succeed in this role, we are looking for the following skills and experience:

  • Degree in engineering / software engineering / sciences .
  • At least 5 years’ experience in design control processes or R&D.
  • Knowledge of medical quality management systems and of FDA QSR.
  • Experience with Software QA and Software Development LifeCycle (SDLC).
  • Knowledge and experience with manufacturing and design controls in medical devices.
  • Qualification as certified quality engineer ISQ.ASQ - an advantage.
  • Good interpersonal skills and understanding of the business development environment.
  • Clear thinking, ability to work in cooperation with other functions in the company [R&D, engineering etc.].
  • Prepared to commute to the different company sites as part of responsibilities of the job.