September 5, 2017

Quality & Regulatory Engineer, Fidmi Medical

Description

The Fidmi Medical quality and regulatory engineer is responsible for the company’s quality processes.

Primary Responsibilities

The quality and regulatory engineer is responsible for the company’s quality processes.

  • Overseeing design and control processes of subcontractors’ production lines
  • Developing a quality exercise program, reviewing design process and managing implementation of SOPs
  • Performing internal quality audits and participation in MRB committee
  • Participating in the development of regulatory and technical file processes
  • Working with international authorities such as the notified bodies and regulatory consultants
  • Managing and tracking updates (QMS)
  • Managing customer complaints

Skills & Experience

  • B.Sc., engineering, life science, or related discipline
  • Certified Quality Engineer (CQE) or other quality certification

 

  • At least 3 years’ hands-on experience as QA in medical devices
  • At least 3 years’ experience in regulation of medical devices
  • Proven experience in 510(k) filing, product risk evaluation, and technical file management
  • ISO 13485 experience
  • Experience working with subcontractors
  • Strong writing skills
  • Excellent English

The qualified candidate:

  • Creative thinker, open-minded
  • Ability to work in a systematic, orderly process
  • Ability to work independently
  • Willingness to work hard

How To Apply

Location: Caesarea/Yokneam, Israel

Send CV to Shahar Millis.

Career Categories

Trendlines Portfolio Companies

About Our Company

The Trendlines Group is an innovation commercialization company. Trendlines invents, discovers, invests in, and incubates innovation-based medical and agricultural technologies. As intensely hands-on investors, we are involved in all aspects of our portfolio companies from technology development to business building. Simply stated, we create and develop companies to improve the human condition.
Font Resize
Contrast