Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEMs to enhance the lives of patients worldwide
Job Summary
Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEMs to enhance the lives of patients worldwide.
The role involves applying intensive and diversified knowledge of Quality Systems Management principles to ensure internal and external customer expectations are met or exceeded.
You will drive continuous QMS improvement, support quality audits, manage supplier quality programs, and participate in risk mitigation strategies.
Matching Summary
Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEMs to enhance the lives of patients worldwide.
Skills & Requirements
Must-have
Quality Management Systems (QMS)
Supplier Quality Management
FDA regulations compliance
Quality Audits support
Quality metrics reporting
Continuous QMS improvement
CAPA and NC management
Nice-to-have
Lead auditor qualification
Problem-solving methodologies training
Cross-functional team collaboration
Strong written and oral communication
Positive can-do attitude
Key Requirements
Bachelor’s degree in Science/Engineering or related field
5+ years experience in similar role
3+ years progressive Quality Systems experience
Knowledge of 21 CFR 820, CFR Part 11, ISO 13485, EU MDR, MDSAP, cGxP
Experience in Medical Device or regulated industry