Quality Engineer

Katalyst Healthcares and Life Sciences

Summary
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.

Requirements:

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.

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Vacancy posted 2 days ago

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