Quality Systems Auditor
About the role
How You Will Make An Impact At LifeNet Health, as the Quality Systems Auditor, you will make an impact by leveraging your expertise, collaboration, and commitment to excellence to help advance our mission of Saving Lives, Restoring Health, and Giving Hope. Through your daily work, you will contribute to innovative solutions, operational excellence, and meaningful outcomes that support donors, patients, healthcare providers, and our communities. Whether driving strategic initiatives, improving processes, supporting customers, advancing research, developing talent, or ensuring quality and compliance, your contributions will help strengthen our ability to transform lives and shape the future of regenerative medicine.
Responsibilities
- Perform all aspects of internal quality audits, including planning, initiation, observations, interviews, analysis, reporting, and verification of corrective and preventive actions, while maintaining audit files.
- Assist with tissue supplier and distribution intermediary audits.
- Support third-party audits by regulatory agencies and business partners.
- Provide guidance for LifeNet Health's Zone Assessment Program.
- Lead cross‑functional projects.
- Promote problem‑solving methods such as 8D.
- Create and revise SOPs to meet QSR/GTP, AATB, and ISO requirements.
- Review CAPA investigations for completeness and effectiveness.
- Serve as a technical resource for CATSWeb activities.
- Provide training as needed.
Requirements
2 years with degree or 6 years without degree experience in quality or operations related activities in tissue banking, blood banking, medical device, clinical trial or pharmaceutical.