Quality Systems Engineer Iii

212forge

Quality management systems (qms)
Supplier quality management
Regulatory compliance with fda and iso
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 standards, supporting audits, managing supplier quality, and driving continuous improvement across multiple departments.
  • Employees are expected to uphold Integer’s core values, support a culture of quality and continuous improvement, and contribute to achieving global quality KPIs.

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 Support
  • Continuous QMS Improvement
  • CAPA and NC Management
  • Microsoft Office Proficiency

Nice-to-have

  • Lead Auditor Qualification
  • Problem-Solving Methodologies Training
  • Cross-Functional Team Collaboration
  • Strong Written and Oral Communication
  • Positive Can-Do Attitude
  • Innovation and Continuous Improvement
  • Support for Environmental Health & Safety Programs

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)
  • U.S. work authorization

Work Rights

U.S. work authorization required

Tailored Resume

Cover Letter