Description
We are looking for a
Computer System Validation Engineer (m/f)
Reference: -en
Start: asap
Duration: 2 MM
Place: in the Olten region
Branch: Medizintechnik
Your tasks:
- Ensure that all validation activities are carried out and reported in a timely manner
- Functional risk assessment, test script(s), test report, residual risk assessment, traceability matrix, compliance report
- User requirement specification, risk assessment type 1, compliance plan, technical specification, design specification, module specification, functional risk assessment, hardware qualification table, test plan, source code review, test script(s), test report, residual risk assessment, traceability matrix, compliance report
- Lead by example, inculcating the credo values in all actions within the workplace
Your qualifications
- In-depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
- Very good understanding of GMP, compliance, validation practices including the system development life cycle and regulatory expectations
- Working experience of validation computer systems for use in a FDA regulated environment
- Profound working experience in a regulated industry and profound experience in carrying out validations
Skills:
- Qualification/validation specialist