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 primary purpose of this position is to apply intensive and diversified knowledge of Quality Systems Management principles and practices to ensure customer expectations are met or exceeded.
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 with FDA and ISO
Quality Audits support
Quality metrics preparation and reporting
Continuous QMS improvement
Problem-solving methodologies
Nice-to-have
Lead auditor qualification
Cross functional team collaboration
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