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 ensuring compliance with quality systems and regulatory requirements, supporting audits, driving continuous improvement, and managing supplier quality programs.
Employees are expected to embody Integer’s core values including Customer focus, Innovation, Collaboration, Inclusion, Candor, and Integrity while pursuing excellence.
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
CAPA and complaint investigations
Cross functional collaboration
Nice-to-have
Lead auditor qualification
Problem-solving methodologies training
Strong written and oral communication
Positive can-do attitude
Innovation and continuous improvement
Subject matter expert recognition
Key Requirements
Bachelor’s degree in Science/Engineering or related field
5+ years experience in similar role
3+ years progressive Quality Systems experience in Medical Device or regulated industry
Knowledge of 21 CFR 820, CFR Part 11, ISO 13485, EU MDR, MDSAP, cGxP