Quality Systems Engineer Iii

2kilo

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 and specialized battery markets, guided by six core values including Customer focus, Innovation, and Integrity

Job Summary

  • Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEMs and specialized battery markets, guided by six core values including Customer focus, Innovation, and Integrity.
  • The role involves ensuring compliance with internal and external quality standards, supporting audits, driving continuous QMS improvements, and managing supplier quality programs to meet or exceed customer expectations.
  • Employees are expected to support a culture of quality and continuous improvement, contribute innovative solutions, and collaborate across functions to achieve global quality KPIs and organizational goals.

Matching Summary

Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEMs and specialized battery markets, guided by six core values including Customer focus, Innovation, and Integrity.

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

Nice-to-have

  • Cross-functional Team Collaboration
  • Continuous Improvement and Innovation
  • Strong Written and Oral Communication
  • Problem-solving Methodologies Training
  • 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
  • Training in problem-solving methodologies

Work Rights

Not specified

Tailored Resume

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