Quality Engineer II
ViantFremont, California, United States
Posted April 10, 2026
121264 - 126000 USD
Full Time
About the Company
Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices.
Job Description
The Quality Engineer II is responsible for ensuring quality activities are performed in accordance with 21 CFR 820, ISO 13485, ISO 14971 and other relevant FDA and International regulations. The position requires experience with quality management systems, sterilization validations, biological risks, and product development oversight for medical devices.
Requirements
- Bachelor's degree or equivalent in Biomedical Engineering or a related field
- 2 years related experience
- 24 months of experience with ensuring quality activities are performed in accordance with 21 CFR 820
- 24 months of experience with providing product development oversight for Class II and III medical devices
- 24 months of experience with conducting and evaluating biological risks for Class III implantable devices
- 24 months of experience with designing and implementing Device Master Record (DMR) features
- 24 months of experience with developing objective evidence through data collection and statistical analyses
- ASQ Six Sigma Yellow Belt Certification
Benefits
- Health insurance
- Retirement plan
- Paid time off
- Stock options