Software validation engineer, medical domain.
Vasa Consulting AB / Datajobb / Göteborg
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hela Sverige We are on behalf of one of our customer in Gothenburg looking for a consultant for the position as a Software validation engineer within the medical domain.
Short recruitment time on this assignment, apply ASAP!
Job description:
• Perform and review of Computerized System Validation
• Responsible for Quality Review of Computerized System Validation documentation
• Participate in Computerized System Validation Projects
• Improve the Computer Software Validation Process
Required competence:
• Engineering or science degree.
• Knowledge of FDA Quality System Regulation 21 CFR Part 11
• Experience of Computerized System Validation
• Experience of Risk Management
• Experience of Configuration and Change Management
• Knowledge of Process Validation
• Knowledge of ISO 13485 Medical Devices ? Quality Management Systems ? Requirements for regulatory purposes
• Knowledge of FDA Quality System Regulation 21 CFR Part 820
• Experience of Quality Systems for Medical Device Company
• Excellent English language skills
• Computer experience of commonly used Microsoft programs
• Candidates must be good team players with attention to detail, self-disciplined, able to manage their own time and workload, proactive and motivated
• Candidates shall also have good written and verbal communication skills in English and preferably also in Swedish.
Wanted competence
• Qualification to act as an Auditor
• GAMP 5
• Knowledge of ISO 14971 'Medical Device' Application of risk management to medical devices
Start: August
Duration: expected assignment end is 2014-12-22
Location: Göteborg
Work load: 100%
Working language: Swedish & English
Please, apply directly via mail with:
• your updated CV in .doc format
• 2 references (people)
• information on when you are available to start
• motivate why you believe you are suitable for this position
Remember that a well written CV and application is your way to the interview!
Also note that we might terminate this job-ad as soon as we find the right candidate, apply ASAP.
Publiceringsdatum2013-06-20Arbetstider och omfattningTillsvidare
Heltid
ErsättningFast lön
Så ansöker duAnsökan kan skickas till e-postadress:
magnus.johnsson@consultant.comFöretagVasa Consulting AB
AdressVasa Consulting AB
43190 MÖLNDAL
Jobbnummer 1588010
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