Sriven Systems Inc.Remote
Quality Engineer- Medical devices
United States of America
Full Time
5 days ago
H1B Sponsor Likely
Key skills
FDA complianceISO 13485 complianceCAPA managementNCR managementRoot Cause AnalysisProcess ValidationIQ/OQ/PQRisk ManagementFMEAInternal AuditsGMP documentationGDP documentationMedical Device manufacturing quality
About this role
Sriven Systems Inc. is seeking a Quality Engineer with experience in Medical Device manufacturing and quality systems. The role involves supporting CAPA, NCR, complaint investigations, risk management, process validation, and ensuring compliance with FDA, ISO 13485, and GMP regulations.
Responsibilities:
- Responsible for supporting CAPA, NCR, complaint investigations, risk management, process validation, and compliance with FDA, ISO 13485, and GMP regulations
- Must work closely with cross-functional teams to ensure product quality, regulatory compliance, and continuous process improvement
Requirements:
- Experience in Medical Device manufacturing and quality systems
- Support for CAPA, NCR, complaint investigations
- Risk management
- Process validation
- Compliance with FDA regulations
- Compliance with ISO 13485 regulations
- Compliance with GMP regulations
- Ability to work closely with cross-functional teams
- Ensure product quality
- Ensure regulatory compliance
- Continuous process improvement
- FDA & ISO 13485 compliance
- CAPA / NCR management
- Root Cause Analysis (RCA)
- Process Validation (IQ/OQ/PQ)
- Risk Management & FMEA
- Internal Audits
- GMP / GDP documentation
- Medical Device manufacturing quality support