The primary purpose of this position is to apply intensive and diversified knowledge of Quality Systems Management principles and practices in broad areas of assignments and related fields
Job Summary
The primary purpose of this position is to apply intensive and diversified knowledge of Quality Systems Management principles and practices in broad areas of assignments and related fields.
You will monitor compliance with company policies and procedures and support Quality Audits (Internal and External) activities, including auditing and providing support to address nonconformities.
You will provide QMS support throughout the organization and assisting with management and execution of CAPAs, NCs, complaint investigations, SCARs, etc.
Matching Summary
The primary purpose of this position is to apply intensive and diversified knowledge of Quality Systems Management principles and practices in broad areas of assignments and related fields.
Skills & Requirements
Must-have
Quality Management Systems (QMS)
Supplier quality management
Regulatory requirements
CAPA, NC, SCAR management
Continuous QMS improvement
Risk mitigation strategies
Nice-to-have
Positive, can-do attitude
Innovation and creativity
Collaboration with cross-functional teams
Problem-solving methodologies
Key Requirements
Bachelor's degree in Science/Engineering or 5+ years experience
3+ years progressive Quality Systems experience
Medical Device, Pharmaceutical, or regulated industry
Knowledge of 21 CFR 820, CFR Part 11, ISO 13485, EU MDR, MDSAP, cGxP