Software Quality Engineer

Abbott

Kilkenny, Ireland
Not specified; base pyy n/a; range may vary by loc...
Not specified (likely onsite due to the nature of the role)
21 cfr part 11 compliance
Iso 13485 knowledge
Iec 62304 software lifecycle
Abbott is seeking a Software Quality Engineer for their Kilkenny site, focusing on ensuring software compliance and quality in regulated healthcare processes. The role involves leading software validation activities, developing documentation, and collaborating with cross-functional teams to maintain high standards in software quality

Job Summary

  • This role ensures all computerized systems and software used in regulated processes meet stringent quality standards and comply with global regulations.
  • You will lead software validation activities for new and existing systems while developing documentation aligned with FDA, ISO, and Abbott policies.
  • Join a global healthcare leader to help shape the future of software quality and compliance in diabetes care technology.

Matching Summary

Match Score: 85

Abbott is seeking a Software Quality Engineer for their Kilkenny site, focusing on ensuring software compliance and quality in regulated healthcare processes. The role involves leading software validation activities, developing documentation, and collaborating with cross-functional teams to maintain high standards in software quality.

Salary

Not specified; Base pay N/A; Range may vary by location

Skills & Requirements

Must-have

  • 21 CFR Part 11 compliance
  • ISO 13485 knowledge
  • IEC 62304 software lifecycle
  • FDA regulated environment experience
  • Computerized system validation

Nice-to-have

  • Risk-based validation approach
  • Data integrity principles
  • Cross-functional collaboration skills
  • Continuous improvement initiatives
  • Vendor site travel capability

Key Requirements

  • Degree in IT, Engineering, or Science
  • 4-5 years in software validation within medical device sector
  • Experience with 21 CFR 820 and GxP guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter