Provider of medical technology for spine surgery. The company’s proprietary Aprevo™ digital-to-device 3-D printed implant system for spine is the first-ever surgical implant to be designated by the FDA as a breakthrough technology. Backed by B Capital.
About the role
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.
What they're looking for
- Plan agenda and lead CAPA meetings (present requests, take meeting minutes, and take actions per Board’s direction)
- Manage CAPAs in electronic system (document due dates, activities, and promote through workflows and approvals)
- Plan and lead root cause analysis meetings and develop corrective action plans with content subject matter experts (SME)
- Assess previous audit findings to establish priorities and strategies
- Prepare audit plans, perform audits (assess objective evidence to determine conformity to requirements, including ranking the levels of nonconformance findings), and complete audit reports
- Support customer and regulatory audits, including audit response follow-up
More about this role
About Carlsmed
Our mission is to improve outcomes and decrease the cost of healthcare for spine surgery and beyond. The Carlsmed aprevo® personalized surgery platform is designed to improve the standard of care for spine surgery one patient at a time.
Position 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. In this capacity, the QA Specialist will work with a significant degree of independence and self-direction to ensure the establishment, implementation, and verification of companywide QMS systems for regulatory compliance.
Responsibilities
- Plan agenda and lead CAPA meetings (present requests, take meeting minutes, and take actions per Board’s direction).
- Manage CAPAs in electronic system (document due dates, activities, and promote through workflows and approvals).
- Plan and lead root cause analysis meetings and...
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