Quality Assurance Technician - Allentown LLC
Job in
Branchburg Township, Somerset County, New Jersey, USA
Listed on 2026-06-26
Listing for:
Gravity Engineering Services Pvt Ltd.
Full Time
position Listed on 2026-06-26
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Job Description & How to Apply Below
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.
- 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.
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