Quality Assurance Specialist
CarlsmedCarlsbad, California, United States
Posted November 20, 2025
80000 - 90000 USD year
Full Time
About the Company
Carlsmed is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Job Description
As a QA Specialist, you will work on projects related to proprietary implants, instrumentation, and design automation systems to enable personalized surgery. The Quality Assurance department encompasses activities related to Documentation Control, Change Control, Corrective Action and Preventive Action, eQMS Administration, Field Actions, Internal Audits and Third-Pary Audits, and Quality Metrics.
Requirements
- Lead Auditor certified (ISO 13485) preferred
- Training in or good working knowledge of 21CFR820, ISO 13485, MDSAP, and ISO 14971
- Training in or good working knowledge of root cause analysis tools
- Advanced Excel Skills (VLOOKUP, Pivot Tables, forms, data analysis, etc...)
- Advanced PowerPoint skills (i.e. Excel chart linking and template design)
- Effective technical writing and verbal communication skills
Benefits
- 100% monthly healthcare, dental & vision insurance premiums
- 401(k) plan with employer matching
- Unlimited PTO