QA Testing Director /Manager/SME Tanisha Systems
Santa Clara, CA30+ days ago
- Full-time
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Skills
- Analysis Skillsunmatched
- Biomedical Engineeringunmatched
- Biotech and Pharmaceuticalunmatched
- Cleanroomunmatched
- Code of Federal Regulationsunmatched
- Communication Skillsunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Cross-Functionalunmatched
- Documentationunmatched
- External Auditunmatched
- FDA (Food and Drug Administration)unmatched
- GMP (Good Manufacturing Practices)unmatched
- ISO (International Organization for Standardization)unmatched
- Internal Auditunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Medical Equipmentunmatched
- Process Validationunmatched
- Quality Assuranceunmatched
- Quality Engineeringunmatched
- Quality Managementunmatched
- Quality Metricsunmatched
- Regulatory Complianceunmatched
- Research & Development (R&D)unmatched
- Root Cause Analysisunmatched
- Software Validationunmatched
- System Validationunmatched
Description
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:
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.
Numbers & Facts
| Location | Pleasanton, CA |
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