Quality Engineer
Job in
Pleasanton, Alameda County, California, 94566, USA
Listed on 2026-08-05
Listing for:
Katalyst Healthcares & Life Sciences
Full Time
position Listed on 2026-08-05
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist -
Engineering
Quality Engineering, Biomedical Engineer, Regulatory Compliance Specialist
Job Description & How to Apply Below
Quality Engineer
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.
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