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 compliance with regulatory and company standards while driving continuous improvement.
You will support a culture of quality and continuous improvement throughout the organization to ensure achievement of Global Quality KPIs and goals.
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
Regulatory Compliance (FDA, ISO 13485)
Quality Audits and Nonconformity Support
Quality Metrics Reporting
Continuous QMS Improvement
Cross-functional Collaboration
Nice-to-have
Lead Auditor Qualification
Problem-solving Methodologies Training
Strong Written and Oral Communication
Positive Can-do Attitude
Innovation and Creativity
Customer Focus
Respectful Interaction
Key Requirements
Bachelor’s degree in Science/Engineering or related field or 5+ years experience
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
Experience with CAPAs, NCs, complaint investigations, SCARs