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 and Nonconformity 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 Continuous Improvement
Subject Matter Expert in Quality Systems
Key Requirements
Bachelor’s degree in Science/Engineering or related field or 5+ years experience
3+ years progressive Quality Systems experience in regulated industry
Knowledge of 21 CFR 820, CFR Part 11, ISO 13485, EU MDR, MDSAP, cGxP
Experience in Medical Device Quality System and Supplier Quality Management
Proficiency in Microsoft Office
Training in problem-solving methodologies such as 8D, RCA, 5-Why, Ishikawa