Quality Systems Engineer Iii

126

Quality management systems (qms)
Fda regulations
Supplier quality management
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 monitor compliance with company policies and procedures and support Quality Audits (Internal and External) activities, including auditing and providing support to address nonconformities.
  • You will be responsible for Quality metrics preparation and reporting, including metrics for Supplier performance.

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 Management Systems (QMS)
  • FDA regulations
  • Supplier quality management
  • CAPA, NC, SCAR management
  • Continuous QMS improvement

Nice-to-have

  • Positive, can-do attitude
  • Innovation and creativity
  • Collaboration with cross-functional teams
  • Subject matter expert

Key Requirements

  • Bachelor's degree in Science/Engineering or 5+ years experience
  • 3+ years progressive Quality Systems experience
  • Knowledge of 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