Quality Engineer for Medical Devices

Job Summary

A company is looking for a Quality Engineer - Design History Files.

Key Responsibilities

• Review existing design history files and identify missing documents
• Utilize Vault Systems to manage document workflow and generate risk documentation
• Coordinate and conduct design reviews with cross-functional teams

Required Qualifications

• B.S. degree in Biomedical, Mechanical, or Materials engineering from an ABET-accredited school or equivalent
• 0 to 5 years of experience in quality engineering for medical devices
• Familiarity with drafting standards and geometric dimensioning and tolerancing (GD&T)
• Strong background in DHF documentation authoring and execution
• Ability to work effectively within cross-functional teams