onsite
Quality Assurance Technician - Allentown LLC
Software Engineer
Perform QA testing and release support for medical device sterilization processes, ensuring compliance with FDA regulations, CFR 210/211, ISO standards, and validated process parameters.
About the role
Key Responsibilities
- Review and verify sterilization batch records against validated parameters and regulatory requirements.
- Monitor real‑time process controls for sterilization cycles and flag deviations.
- Support release decisions by compiling and assessing documentation for compliance with FDA QMSR, CFR 210, CFR 211, and ISO 13485.
- Conduct routine equipment qualification, calibration, and preventive maintenance activities.
- Participate in internal and external audits, providing evidence of compliance and corrective actions.
Requirements
- Associate’s degree or higher in a scientific/technical field or equivalent experience in medical device QA.
- Hands‑on experience with sterilization technologies (e.g., steam, EO, radiation) and related documentation.
- Strong knowledge of FDA regulations, CFR 210/211, and ISO 13485 quality system requirements.
- Proficiency in data review, trend analysis, and generating compliance reports.
- Excellent attention to detail, problem‑solving skills, and ability to work in a regulated, on‑site environment.
Skills
software developmentsystem designproblem solving