Senior Software Quality Assurance Engineer
- Hiring Organisation
- Implantica
- Location
- Southampton, UK
- Employment Type
- Full-time
downstream processes. • Develop Quality Plans for the implementation of new processes, enhancements, or continuous improvements to existing processes • Prepare documentation, plan, schedule, and execute validation activities of the QMS software utilizing a risk-based approach. Ensure compliance to medical device industry regulations, including 21 CFR Part 11, EU GMP Annex … processes. • Support Regulatory audits/inspections as a Subject Matter Expert (SME). Your Profile: • Minimum 5 years of related experience in QMS Software Validation with a Bachelor's degree; or 3 years of related experience with a Master's degree. NOTE: A diploma, certificate or other evidence of formal ...