Quality Systems Engineer Iii

Integer

Quality management systems (qms)
Supplier quality management
Regulatory compliance (fda, iso 13485)
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 ensuring compliance with quality, safety, environmental, and regulatory requirements while driving continuous improvement across multiple departments.
  • 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 Support
  • CAPA and NC Management
  • Quality Metrics Reporting

Nice-to-have

  • Lead Auditor Qualification
  • Problem-Solving Methodologies
  • Cross-Functional Collaboration
  • Strong Communication Skills
  • Positive Can-Do Attitude

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
  • Lead Auditor qualification (advantage)
  • Proficiency in Microsoft Office

Work Rights

Not specified

Tailored Resume

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