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, ensuring compliance with regulatory and company standards, and driving continuous QMS improvement.
The position supports a culture of quality and continuous improvement, requiring collaboration across multiple functional departments and occasional travel.
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 with FDA and ISO
Quality Audits and Nonconformity Support
Continuous Improvement and Risk Mitigation
Cross-functional Team Collaboration
Nice-to-have
Strong Problem-solving Methodologies
Lead Auditor Qualification
Positive Can-do Attitude
Clear Professional Communication
Innovation and Creativity
Supportive of Environmental Health & Safety Programs
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