Quality Engineer, Medical Device (Irvine, CA $80K-$90K)
SNAPSHOT!
Looking for a chance to join a world-class medical device firm in Orange County experiencing explosive growth? Our client is setting new standards in glaucoma treatment and is committed to expanding patient treatment and improving outcomes through innovative minimally invasive glaucoma surgical (MIGS) solutions, the fastest-growing segment of the ophthalmology market! Offering next-generation MIGS technology that addresses unmet needs in the global glaucoma market, our client is committed to improving glaucoma patient outcomes using evidence-based research!
Immediate opening for a Quality Engineer in Irvine CA who possesses:
- 2-5+ years of experience in medical device and operations
- Relatable bachelors degree
Duties and Responsibilites:
- Provide quality assurance input and review of design and development planning, inputs/outputs of development, design reviews, design validation and verification, human factors analysis, design history file, and device master record development and maintenance.
- Drive risk management file establishment and maintenance throughout the product life-cycle. Assist in establishing hazards list, assessing the severity of harm and ensuring consistency between risk management files on systems.
- Lead CAPA investigations and support CAPA investigation teams relating to product functionality and design improvement. Support audits of the quality management system, specifically relating to Design Control, Risk Management, CAPA, Complaints, and related processes.
- Assist the development team in creating, optimizing and validating mechanical and analytical test methods. Supporting regulatory submissions by reviewing content for accuracy and comprehensiveness.
- Identify, propose and drive opportunities for improvement, including review and revision of procedures and associated documents.
If you’d like to explore, send your resume to admin@snapstaffing.com and we’ll follow up with you ASAP!