Quality Engineer IV #JN -062021-65091

Irvine, California
Industry: QA Testers
Job Number: JN -062021-65091

Position Summary:

  • This is a hands-on position, which the right candidate will be able to adapt quickly to changing priorities and manage the integration activities within the Aesthetics business.
  • The ideal candidate will provide support to the Quality Operations team to maintain compliance during the integration activities.

 Responsibilities:

  • Manage multi discipline groups for project execution and implementation
  • Serve as an owner of the QMS integration activities for one of the Aesthetics sites.
  • Responsible for the completeness of the integration activities; Create, review, and approve controlled documents on an electronic document control system.
  • Coordinates and/or provides training to staff in Quality System documents, work instructions.
  • Provides ongoing development and maintenance of training materials and records during integration activities.
  • Review and assess QMS changes for completeness, accuracy, and effectiveness.
  • Collaborate with the team to define and implement systems that enhance efficiency, productivity, and quality;
  • Work towards resolving quality issues
  • Ensure that procedures and processes are maintained and updated to be consistent with regulatory changes including the development of more efficient QMS processes and global QMS processes;
  • Maintain and update the integration plan
  • Recognize areas for continuous improvement
  • Perform other duties as may be required by management.

 Minimum Qualifications, Skills, and Abilities:

  • Bachelor’s Degree in Engineering.
  • 5+ years of experience within the medical device space, R&D, regulatory or design development.
  • Effective verbal and written communication skills; ability to write clear procedures
  • Exhibit good problem solving and analytical skills
  • Proficient in the use of Microsoft Office
  • Knowledge in FDA QSR, ISO 13485 regulations
  • Knowledge in Root Cause Analysis tools


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