Quality Systems Engineer Iii

Integer

Quality systems management principles
Qms, safety, environmental, security
Fda regulations
The primary purpose of this position is to apply intensive and diversified knowledge of Quality Systems Management principles and practices in broad areas of assignments and related fields

Job Summary

  • The primary purpose of this position is to apply intensive and diversified knowledge of Quality Systems Management principles and practices in broad areas of assignments and related fields.
  • You will ensure that Integer internal and external customers’ expectations are met or exceeded.
  • You will drive continuous QMS improvement by developing procedures and gaining alignment across multiple functional departments.

Matching Summary

The primary purpose of this position is to apply intensive and diversified knowledge of Quality Systems Management principles and practices in broad areas of assignments and related fields.

Skills & Requirements

Must-have

  • Quality Systems Management principles
  • QMS, Safety, Environmental, Security
  • FDA regulations
  • Supplier quality management
  • CAPA, NC, complaint investigations

Nice-to-have

  • positive, can-do attitude
  • belief that failure is not an option
  • innovation and creativity
  • collaboration with cross functional teams

Key Requirements

  • Bachelor's degree in Science/Engineering
  • 5+ years experience in similar role
  • 3+ years progressive Quality Systems experience
  • Medical Device, Pharmaceutical, or regulated industry
  • 21 CFR 820, CFR Part 11, ISO 13485, EU MDR, MDSAP, cGxP
  • Lead auditor qualification is an advantage
  • Proficient in Microsoft Office applications
  • Training in 8D, RCA, 5-Why, Ishikawa

Work Rights

Not specified

Tailored Resume

Cover Letter