Computer System Validation Engineer (m/f)

Job type:
on-site
Start date:
asap
Duration:
2 MM
From:
Hays AG
Location:
the Olten region
Published at:
09/17/2016
Country:
flag_no Switzerland
Contact person:
Kerstin Werner
Project ID:
1204654

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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