Quality Engineering and Regulatory Affairs Intern
Exsurco MedicalOhio, United States
Posted January 16, 2026
Part Time
About the Company
Exsurco Medical, Inc. designs and manufactures advanced medical devices for tissue banking, skin grafting, and wound care, supporting clinicians in delivering life‑saving skin and tissue therapies. The company’s product portfolio includes precision excision instruments, skin recovery and debridement devices, and all‑ograft recovery systems that enable rapid, sterile processing of split‑ and full‑thickness skin grafts and adipose tissue. Exsurco’s vertically integrated manufacturing facility in Wakeman, Ohio—equipped with a Class‑7 cleanroom and ISO 13485 certification—ensures end‑to‑end quality control and rapid time‑to‑market for FDA‑registered products. By combining cutting‑edge excision science with a culture of employee empowerment and a commitment to healing, Exsurco positions itself as a trusted partner for hospitals and tissue banks across the United States.
Job Description
The QA/RA Manager provides hand-on experience in Regulatory Affairs and Quality Management Systems. This includes projects and daily tasks associated with maintaining compliance with domestic quality system as required for Medical Device Manufacturers involved with Clean Room Operations, and through support of other functional departments or product staff in assisting the QA/RA Manager.
Requirements
- Assisting the QA RA Manager with Regulatory Activities, Corporate Quality, oversight of Plant Quality, Microbiology/Sterilization and Document Control
- Participating in the development and execution of installation, operational and performance qualifications of equipment, (IQ, OQ and PQ) including the clean room itself.
- Prepares quality documentation (ERTs, CRTs and Management Review) and reports by collecting, analyzing, and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
