Quality Engineer

October 19, 2021
  • Full Time
  • Maryland

The Quality Engineer will focus on developing, implementing, and performing Quality Assurance and Quality Control related activities to support the products designed and manufactured by Galen Robotics.

Key Activities:

  • Assist in the continuous evaluation and improvement of the Galen Quality System.
  • Serve as an independent reviewer for design reviews.
  • Perform supplier evaluation related activities.
  • Develop metrics to evaluate supplier performance and perform supplier performance evaluations.
  • Maintain and update Supplier Performance Files.
  • Develop and execute incoming raw material inspection activities.
  • Develop and execute in-process manufacturing quality inspection activities.
  • Participate in Risk Management, Design Verification, Transfer and Change activities.

Education:

  • Bachelor’s Degree in engineering or scientific discipline.

Experience:

  • 3 years of medical device, pharmaceutical or other regulated industry (e.g., automotive, nuclear, telecom, defense, etc.) experience
  • 2 years of quality assurance and/or quality control experience in a regulated industry (e.g., medical device, pharmaceutical development, automotive, etc.)

Additional Desired Skills/Qualifications/Competencies:

  • Medical Device product design experience
  • ASQ CQE/CSQE/CQA Certification
  • ISO 13485:2016 Auditor or Lead Auditor Certification
  • Lean and/or 6-Sigma training or certification

Physical Requirements:

  • Must be able to lift 30 lbs.
  • Ability to sit at a desk and/or stand at a manufacturing location for extended periods of time.
  • NOTE: Reasonable accommodations may be made to enable individuals with disabilities to perform this task

To apply for this job email your details to admin@galenrobotics.com