System Engineer 3

Role:                     System Engineer 3
Location:             Seattle, WA
Visa:                     Independent Consultant 
Duration:             Long Term Contract
 
Job Responsibilities
•        Significant leadership experience in role.
•        Knowledge of ISO 13485, FDA's QSR, ISO 14971, the EU's MDD and regulations governing medical devices
•        Bachelor's or Masters degree plus a minimum of 10-20 years of related experience in the medical device or other regulated industry.
•        Working knowledge of application development, testing, and deployment
•        ASQ Software Quality Engineer certification preferred
•        Compliant to internal Quality System requirements and initiatives, as well as all applicable regulations and standards.
•        Review and coordinate with Validation team and ensure work product meets regulations.
•        Participate in phase reviews, write Quality Procedures, as applicable.
•        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
•        Must possess excellent communication (verbal & written) skills
 Responsible for:
•        Translating business and user requirements to product requirements.
•        Developing the product verification strategy.
•        Reviewing verification results to confirm product requirements are met.
•        Identifying and mitigating areas of technical risk by following the product design FMEA process.
•        Communication of V-model maturity during product development to management
•        Review designs, documents, records, for compliance to internal procedures and regulations.
•        Partner with other members of the team to ensure the deliverables

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