Senior Quality Systems Auditor

The role

This person will plan, execute, and report on internal quality system audits. They will support ISO 13485 certification readiness and ongoing QMS surveillance activities.

What you will do

• Develop and maintain the annual internal audit schedule.
• Lead and conduct internal audits of all QMS processes.
• Author audit plans, checklists, and reports.
• Document nonconformities, observations, and opportunities for improvement.
• Assign and track audit findings through closure.
• Collaborate with CAPA owners to ensure root cause analyses and corrective actions.
• Support third-party certification body audits and surveillance activities.
• Assist with preparation and review of QMS documentation for CB audit submissions.
• Provide gap analysis and remediation support.
• Maintain the internal audit program and report metrics to QA leadership.

Required qualifications

• Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, or a related technical discipline.
• Minimum 10 years of experience in Quality Assurance within the medical device industry.
• Minimum 5 years of direct internal auditing experience against ISO 13485 and/or 21 CFR Part 820.
• Demonstrated experience supporting or participating in third-party CB certification audits (ISO 13485).
• Thorough working knowledge of ISO 13485:2016 and 21 CFR Part 820 (QSR/QMSR).
• Proficiency with electronic QMS platforms (e.g., Enlil, ZenQMS, MasterControl, Veeva, or equivalent).
• ISO 13485 Lead Auditor certification (e.g., IRCA, Exemplar Global, or equivalent accredited body), OR ASQ Certified Quality Auditor (CQA), OR ASQ Certified Quality Engineer (CQE) with documented lead

Nice to have

• Experience with Class III and/or Active Implantable Medical Device (AIMD) development and commercialization
• Familiarity with FDA IDE regulations (21 CFR Part 812) and clinical device release processes
• Working knowledge of ISO 14971 (risk management), IEC 62304 (software lifecycle), and/or ISO 10993 (biocompatibility)
• Experience auditing sterilization processes (e.g., EO, radiation) and/or sterile medical device manufacturers
• Exposure to Class III AIMD regulatory submissions (PMA, IDE) or design history file (DHF) review
• Experience in a startup or scale-up medical device environment building QMS infrastructure
• Familiarity with supplier quality management and supplier audit execution
• Experience with ISO 13485 certification pursuit from gap assessment through initial certification

Benefits

• 401(k) with company matching
• Medical, dental, and vision insurance
• Health Savings Account (HSA) & Flexible Spending Account (FSA)
• Life insurance & Employee Assistance Program
• Generous paid time off

About the company

BiVACOR is developing the world's most advanced total artificial heart. They are a team united by purpose working on unprecedented technology.