Quality Systems Engineer Iii

Integer

Quality management systems (qms)
Supplier quality management
Fda regulations compliance
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 functional departments.
  • You will support a culture of quality and continuous improvement throughout the organization to ensure achievement of Global Quality KPI’s 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
  • FDA regulations compliance
  • Quality Audits support
  • Continuous QMS improvement
  • Quality metrics preparation
  • Cross functional team collaboration

Nice-to-have

  • Lead auditor qualification
  • Problem-solving methodologies training
  • Strong written and oral communication
  • Positive, can-do attitude
  • Innovation and creativity
  • Culture of quality and continuous improvement

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

Work Rights

Not specified

Tailored Resume

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