Senior Quality Engineer at Apreo Health · Menlo Park, CA · Joined
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Senior Quality Engineer
Apreo Health · Menlo Park, CA · Just now · 0 applicants
NewOn-siteFull-timeSenior
Pay
Pay not listed
Workplace
On-site
Job type
Full-time
Level
Senior
Source: jobright · Posted by joined-scrapper
About the role
Apreo Health is hiring a Senior Quality Engineer to lead quality engineering for the BREATHE Airway Scaffold, a Class III medical device, ensuring design controls, risk management, and validation activities support the path to IDE and commercialization.
What you’ll do
Lead quality engineering for Class III medical device development
Manage design controls, risk management, and traceability
Oversee verification, validation, and design transfer activities
Support QMS and ensure compliance with ISO 13485 and FDA QSR
Contribute DHF, risk management, and validation documentation to IDE/PMA submissions
Develop scalable controls for incoming inspection and lot release
What you’ll need
Bachelor's degree in engineering, bio-medical, life sciences, or related field
6+ years with MS or 8+ with BS in medical device quality and design controls
Strong working knowledge of DHF/DMR and ISO 14971 risk management
Practical experience with ISO 13485 and FDA QSR in product development
Experience with NCR/NCMR, CAPA, change control, and supplier quality
Must be authorized to work in the United States
Original job description
Apreo Health is developing the BREATHE Airway Scaffold, a therapy for severe emphysema. The Senior Quality Engineer leads quality engineering for a Class III medical device, including design controls, risk management, verification and validation, design transfer, and QMS support as the program advances through IDE and toward commercialization.Education:…