Quality Systems Engineer III

Quality Systems Engineer III

Duration: 6 Months Location: Austin, TX (Hybrid - 3 days in office, 2 remote) Pay Rate:$50.00 - $55.00/hr.

Required Skills (Top 3)

1. Medical Device Quality Systems (QMS)
   • FDA 21 CFR Part 820
   • ISO 13485
   • EU MDR
   • ISO 14971
2. Quality System Compliance & Procedure Development
   • Gap Assessments
   • SOP/Procedure Updates
   • CAPA
   • Design Controls
   • Validation
   • Nonconformance Management
3. Cross-Functional Collaboration
   • Work with Quality, Regulatory, R&D, and Operations teams
   • Drive QMS harmonization across sites

Key Responsibilities

• Support development, implementation, and continuous improvement of the Quality Management System (QMS).
• Perform gap assessments against corporate procedures, FDA, ISO 13485, EU MDR, and ISO 14971 requirements.
• Update and harmonize quality procedures across multiple sites and regions.
• Support QMS elements including:
  • CAPA
  • Design Controls
  • Purchasing Controls
  • Validation
  • Nonconformance Management
• Collaborate with Regulatory, R&D, and Quality teams to ensure compliance.
• Drive quality system standardization and best practices globally.

Required Qualifications

• Bachelor's degree preferred (Engineering/Scientific field preferred).
• 5+ years of Quality Systems, Quality Engineering, or Regulatory Compliance experience.
• Medical Device industry experience is required.
• Strong knowledge of:
  • FDA 21 CFR Part 820
  • ISO 13485
  • EU MDR
  • ISO 14971
• Experience with CAPA, Validation, Design Controls, and Risk Management.