Senior Design Quality Engineer
CircadiaRemote Patient company
El Segundo, United StatesSenior
Headline
EIS Capital
GCI Capital (Toronto)
NOVIT Ventures
Redmile Group
Software Engineering
About the role
TL;DR
Senior Design Quality Engineer to build and lead QMS, design controls, and quality processes.
- •Circadia Health is seeking a Senior Design Quality Engineer to establish and lead quality engineering processes, build and implement a Quality Management System (QMS) aligned with ISO 13485 and FDA QMSR, and own design controls across the product lifecycle.
- •Key Responsibilities Lead the design, implementation, and roll-out of an ISO 13485-compliant Quality Management System.
- •Establish and standardize core quality procedures, including document control, change management, CAPA, and nonconformance.
- •Design and maintain the Post-Market Surveillance (PMS) system and lead CAPA and Nonconformance processes.
- •Support execution and maintenance of design control activities and maintain Design History File (DHF) documentation.
- •Assist in preparation of FDA submission documentation and coordinate with cross-functional teams.
- •Requirements Bachelor's degree in Biomedical Engineering, Software Engineering, Mechanical Engineering, or a related technical field. 5+ years of design quality engineering experience in the medical device or digital health industry.
- •Proven experience building processes from scratch in a fast-paced startup environment.
- •Direct experience building and implementing an ISO 13485 QMS.
- •Deep proficiency in Design Controls, Risk Management (ISO 14971), CAPA management, Complaint Handling, and Post-Market Surveillance (PMS).
Domain expertise
healthcare