Quality Systems Engineer Iii

Integer

Quality management systems (qms)
Supplier quality management
Quality audits support
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 internal and external quality requirements, supporting audits, driving continuous QMS improvement, and managing supplier quality programs.
  • Employees are expected to support a culture of quality and continuous improvement, demonstrate innovation, and collaborate across multiple functional departments.

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
  • Quality Audits support
  • Regulatory compliance with FDA and ISO
  • Quality metrics preparation and reporting
  • CAPA and complaint investigations
  • Cross functional team collaboration

Nice-to-have

  • Lead auditor qualification
  • Problem-solving methodologies training
  • Strong written and oral communication skills
  • Positive can-do attitude
  • Innovation and continuous improvement mindset
  • 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 or Pharmaceutical regulated industry

Work Rights

Not specified

Tailored Resume

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