SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Salary: USD 80,000 - 90,000 / annual
Carlsmed is a medical device company focused on improving outcomes and reducing costs in spine surgery through its aprevo® personalized surgery platform. The Quality Assurance Specialist will work with significant independence to establish, implement, and verify company-wide Quality Management Systems (QMS) for regulatory compliance.
Key responsibilities include:
- Planning and leading Corrective Action and Preventive Action (CAPA) meetings, managing CAPA workflows, and coordinating root cause analysis with subject matter experts
- Planning and conducting internal audits, assessing conformity to requirements, and preparing audit reports
- Supporting customer and regulatory audits, including coordination, documentation, and response follow-up
- Staying current on industry standards and regulatory changes (21 CFR 820, ISO 13485, MDSAP, ISO 14971); performing gap assessments and implementing procedure updates
- Managing Field Actions, including customer notifications and product documentation for recalls
- Monitoring, analyzing, and trending quality and compliance performance indicators using Excel and data visualization tools
- Preparing presentations and coordinating quarterly trend and management review meetings
- Leading process improvement initiatives to streamline QMS procedures and practices
The role requires strong technical writing and verbal communication skills, advanced proficiency in Excel (VLOOKUP, pivot tables, data analysis) and PowerPoint (chart linking, template design), and familiarity with root cause analysis tools.
QUALIFICATIONS & EXPERIENCE REQUIRED:
- Minimum 3 years in the medical device industry
- Minimum 3 years of quality system management/quality assurance experience, including CAPA administration, regulatory interpretation and implementation, system change review for compliance, quality metrics monitoring and trending, and third-party audit coordination
- Minimum 2 years as a lead auditor
- Proven ability to support and implement quality systems and improvements (e.g., ISO 13485 upgrades, MDSAP implementation)
- Demonstrated career progression with increasing responsibilities
- Training in or working knowledge of 21 CFR 820, ISO 13485, MDSAP, and ISO 14971
- Lead Auditor certification (ISO 13485) preferred
- Working knowledge of ISO 27001 preferred
- Training in or working knowledge of root cause analysis tools
- Advanced Excel skills (VLOOKUP, pivot tables, forms, data analysis)
- Advanced PowerPoint skills (chart linking, template design)
- Effective technical writing and verbal communication skills
