System Engineer 3
Job Title: System Engineer 3
Location: Seattle, WA
Duration: 6+ months
• 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
• 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,
16192, Coastal Highway,
Lewes, Delaware, USA