Senior Quality Systems Auditor

Responsibilities

• Develop and maintain the annual internal audit schedule based on risk and regulatory requirements
• Lead and conduct internal audits of QMS processes including design controls, CAPA, and supplier quality
• Document nonconformities and track audit findings through closure and CAPA effectiveness verification
• Support third-party certification body audits and ISO 13485 certification readiness

Requirements

• Minimum 10 years of Quality Assurance experience in the medical device industry
• Minimum 5 years of direct internal auditing experience against ISO 13485 and/or 21 CFR Part 820
• ISO 13485 Lead Auditor, ASQ CQA, or ASQ CQE certification

Preferred Qualifications

• Experience with Class III and/or Active Implantable Medical Device (AIMD) development
• Experience auditing sterilization processes or sterile medical device manufacturers
• Experience in a startup or scale-up medical device environment

Benefits

• 401(k) with company matching
• Medical, dental, and vision insurance
• Generous paid time off

About the Company

BiVACOR is developing the world's most advanced total artificial heart, a technology capable of saving millions of lives around the world.