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

Carlsmed, Inc.; Carlsbad (CA); On-site; USD 80,000 - 90,000; Full time

Job summary

The Carlsmed QA Specialist will work on proprietary implants, instrumentation, and design automation systems to enable personalized spine surgery. You will ensure company-wide QMS compliance through documentation control, change control, CAPA, internal and third-party audits, and eQMS administration.

Key activities include leading CAPA meetings, managing CAPAs, performing root cause analyses, planning audits, and supporting regulatory reviews.

Qualifications

• Lead Auditor certified (ISO 13485) preferred.
• Training in or good working knowledge of 21CFR820, 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.

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 SMEs; implement CAPA actions and monitor effectiveness.
• Assess audit findings to establish priorities; plan annual audit schedule and assign SMEs.
• Prepare audit plans, perform audits, and complete audit reports.
• Support customer and regulatory audits, including audit response coordination.
• Stay up to date on industry standards; interpret and implement changes.
• Lead projects to streamline processes and practices.
• Support Field Actions and monitor performance indicators with data analysis.

Skills

Lead Auditor

21 CFR 820 knowledge

ISO 13485

MDSAP

ISO 14971

ISO 27001

Root cause analysis

Advanced Excel

Advanced PowerPoint

Technical writing

Verbal communication

Job description

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 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 21CFR820, 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 coordination
• Minimum two years experience as lead auditor
• Proven ability to support and implement quality systems and quality improvements (i.e. Upgrade from ISO 13485 2003 to ISO 13485 2016, or implementation of MDSAP).
• Increasing responsibilities whether within the same organization or as a progression within career path.

Equal Opportunity Employer

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.Carlsmedis committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know.

Compensation

The anticipated annual base salary range for this position is $80,000 - $90,000. Individual compensation is determined based on factors such as experience, skills, education, certifications, and geographic location.

In addition to base salary, eligible employees may participate in incentive compensation programs and receive a comprehensive benefits package. Our benefits reflect our commitment to the health and well-being of our employees and their families and include 100% employer-paid medical, dental, and vision insurance premiums, a 401(k) plan with employer matching, and unlimited paid time off (PTO). Your recruiter can provide additional details about our total rewards package during the hiring process.