KH
Quality Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
2 months ago
- CAPA
- Regulatory Compliance
- GMP
2 months ago
We are looking for a Quality Engineer with 0–3 years of experience to support quality systems, validation, CAPA, and compliance activities in a regulated medical device/pharma environment. The role involves working closely with cross-functional teams to ensure product quality and regulatory compliance.
Roles & Responsibilities:
- Support equipment, process, and software validation (CSV, IQ/OQ/PQ).
- Assist with CAPA, non-conformance (Client/MRB), and root cause investigations.
- Maintain quality documentation and analyze quality metrics.
- Support internal/external audits and ensure compliance with FDA, ISO 13485, and GMP requirements.
- Collaborate with Engineering, Manufacturing, and R&D on quality initiatives.
- Bachelor's degree in Engineering, Biomedical Engineering, or a related field.
- 0–3 years of experience in Medical Devices, Pharma, Biotech, or other regulated manufacturing environments.
- Basic knowledge of FDA 21 CFR 820, ISO 13485, CAPA, Validation, and Quality Management Systems.
- Strong analytical, documentation, and communication skills.
- Exposure to CSV, IQ/OQ/PQ, ISO 14971, GMP, or cleanroom environments.
Quality Engineer · Katalyst Healthcares & Life Sciences