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R&D Control Lead

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Location
Oceanside, CA
Salary
$80,000 - $100,000
Job Type
Direct Hire
Date
May 12, 2017
Job ID
2440790

SUMMARY

Responsible for leading R&D team in the control of design documentation and testing of devices in accordance to ISO and FDA guidance and regulations.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Lead design control and project management for new products.
  • Manage R&D Test lab
  • Write Design Verification Test Protocols and Reports.
  • Update and maintain Product Specifications.
  • Coordinate building and testing of prototypes and pre-production devices.
  • Develop and Document new processes and test methods.
  • Communicate tasks, priorities, and status to supervisor and team.\
  • Work adhering to European, US, Canadian and other regulatory and Quality System requirements (ISO, CFR, SOR, MDD, etc.).

EDUCATION, SKILLS AND EXPERIENCE

  • Bachelor's degree (B.S.) in Engineering or technical discipline.
  • 5 years’ experience preferably in a Medical device environment.
  • Experience in Global Quality Systems (i.e., ISO13485, QSRs, etc.) and Medical Device Regulations (CFR, MDD, SOR, etc.) as it relates to department and job duties described within this document.

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