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