Quality Engineer

Pay Rate: BR / Bill Rate: BR Job Title: Quality Engineer: Contractor Requisition ID: TBD Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than BR billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands - Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services - we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services. Responsibilities: Ensure that project requirements for software quality engineering sustaining activities are met. Perform software quality engineering activities for Microarray products in a cGMP environment. Create and revise Quality Software Reports and Risk Analysis. Ensure that software validation activities are compliant to applicable internal and external standards. Coordinate Software Complaint review and closure. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving software quality issues. Follow applicable site and global procedures and ensure that developed validations and respective specifications are accurate with cGMP process. Archive, store and maintain all document files to comply with Corporate and Site policies in a state of audit readiness. Work cross departmentally to address software quality issues. Manage new staff additions to Learning Management System (LMS), user account maintenance, LMS update assessments, and issue monthly training reports. Review and reporting of open CAPAs and deviations Monitor and report on project needs and respond in a timely manner for problems. Minimum Qualifications: B.S. degree in IT, Engineering, Technical or related field 5-10 years of experience in Quality Software Engineering and Validation Experience with Quality Software Engineering design and development processes and Validation in a cGMP and regulated industry Solid communication and interpersonal skills. Good organization and multi-tasking skills, drive for results and complete work on time Working conditions: Works primarily in an office environment,