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Sr CSV Consultant

Job Description

Sr CSV Consultant
Location: Bothell, WA

Duration: 6 months (Extendable)
• Expertise in validation of enterprise wide quality IT systems using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines
• Experience in implementing systems compliant to 21CFR11
• Working knowledge of servers, databases, data migration, and server validation
• Understanding of software risk management (ISO 14971)
• Ensure validations verify data integrity, electronic data storage and data sheet validations.
• Team up with other members of the team to create plans for validating software systems to local site procedures
• Ensure deliverables are robust and meet regulations
• Knowledge of database and server management tools
• Lead quality assurance process from test design to final reports
• Good problem solving skills
• Significant leadership experience in role.

Job Requirements

This role requires expert knowledge of ISO 13485, FDA’s QSR, ISO 14971, the EU’s MDD and regulations governing medical devices shipped to Canada. In addition, diplomacy, flexibility and critical thinking will be required in working closely with all parts of the organization, to ensure robust solutions are applied to processes. The ideal candidate is a self-motivated individual, who is excited by the prospect of working in a dynamic, fast-paced manufacturing environment, and has project management knowledge. 

Job Snapshot

Employment Type Contractor
Job Type QA - Quality Control
Education 4 Year Degree
Experience 10 to greater than 15 years
Manages Others Not Specified
Industry Medical Equipment
Required Travel Not Specified
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Sr CSV Consultant

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