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.
- 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.
- Bachelor’s Degree in engineering or scientific discipline.
- 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
- 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
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