QA Lead - Medical Devices | CAPA, Audits & Unlimited PTO

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 company wide 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 develop corrective action plans with content subject matter experts (SME).
  Implement corrective action plans with support of SME and monitor and verify CAPA effectiveness.
• Assess previous audit findings to establish priorities and strategies.
  Plan annual audit schedule, determine and assign SMEs to audits, establish audit content, and allocate time.
• 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.
  Specifically, reserve meeting space, coordinate SME participation per audit agenda, documenting the audit, document and record retrieval and preparation, and submission of audit response.
• Stay up to date on industry standards and regulatory changes.
  Interpret standards and regulatory rules or rule changes, perform gap assessments between corporate procedures and applicable standards and regulatory rules, and implement them through the release or revision of corporate procedures.
• Actively seek and lead projects to streamline processes, procedures, and/or practices.
• Supports Field Action, which includes managing customer notification, product documentation, and follow-up activities to support closure of Field Action/Recalls.
• Monitor, gather, analyze, and trend key quality and compliance performance indicators utilizing pivot tables, charts, and graphs.
• Prepare presentations of trend data for quarterly trend and management review meetings.
  Coordinate quarterly trend and management review (schedule, document notes and attendance, and documentation archiving).

Qualifications

• Lead Auditor certified (ISO 13485) preferred
• Training in or good working knowledge of 21
  
  CFR
  820, ISO 13485, MDSAP, and ISO 14971
• Working knowledge of ISO 27001 preferred
• 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

Experience

• Minimum three years in the medical device industry
• Minimum three years of experience in quality system management/quality assurance
  • CAPA (Corrective Action Preventive Action) administration;
  • Interpreting and implementing regulatory and standard requirements;
  • Reviewing system changes for continued compliance;
  • Monitoring, gathering, analyzing, and trending key quality and compliance performance indicators; and
  • Third party audit…