System Engineer 3

Job Title: System Engineer 3

Location: Seattle, WA
Duration: 6+ months

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 

Thanks & Regards,

Rajendra Mane



16192, Coastal Highway,

Lewes, Delaware, USA

Phone: 302-200-2321


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