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 customer expectations and regulatory requirements are met or exceeded.
You will support continuous QMS improvement, participate in supplier management programs, and contribute to a culture of quality and continuous improvement throughout the organization.
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 13485
Quality audits and nonconformity management
Continuous improvement of QMS
Quality metrics preparation and reporting
Nice-to-have
Lead auditor qualification
Problem-solving methodologies training
Cross functional team collaboration
Strong written and oral communication skills
Positive, can-do attitude
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