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, supporting audits, driving continuous QMS improvements, 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
Internal and External Quality Audits
Regulatory Compliance with FDA and ISO
Quality Metrics Preparation and Reporting
CAPA and Nonconformity Management
Nice-to-have
Lead Auditor Qualification
Problem-Solving Methodologies Training
Cross-Functional Team Collaboration
Strong Written and Oral Communication
Positive Can-Do Attitude
Continuous Improvement Culture Support
Key Requirements
Bachelor’s degree in Science/Engineering or 5+ years related experience
3+ years progressive Quality Systems experience in Medical Device or regulated industry
Working knowledge of 21 CFR 820, CFR Part 11, ISO 13485, EU MDR, MDSAP, cGxP
Proficiency in Microsoft Office
Experience with problem-solving tools like 8D, RCA, 5-Why, Ishikawa