Job Information
BIOMERIEUX, INC. Software Quality Engineer in SALT LAKE CITY, Utah
Software Quality Engineer
Location: Salt Lake City, UT, United States
Position Type: Unfixed Term
Job Function: Quality
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A world leader in the field of in vitro diagnostics for more than 60 years, bioMerieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.
In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.
Description
This role will oversee and support the implementation of software lifecycle deliverables, including validation, change management, and decommissioning of Non-Product Software (NPSW). This includes the review and approval of validation documentation and other computerized system lifecycle documentation to ensure conformance with site and global procedures, as well as ISO, QSR, GXP, and/or GAMP regulations. This position will routinely interact with engineers, project managers, business unit owners, and senior personnel responsible for Non-Product Software and infrastructure, particularly in relation to Salt Lake City operations. Additionally, this role will represent Salt Lake City as the site software QA lead or Validation Engineer when globally deployed computer systems are implemented.
The Software Quality Engineer role will lead critical projects with minimal supervision, ensuring the highest standards of software quality by advocating for best practices in Software Quality, DevOps, Security, and Agile methodologies. This position will attend Non-Product Software Change Control Board meetings, provide expert advice on validation and change management, support CAPA and investigations, and oversee documentation to ensure compliance with industry standards. Expertise in CFR Part 11 and Computer System Validation (CSV) will be crucial, as will the ability to lead software verification and validation activities, perform risk evaluations, and identify improvements to our Quality Management System. Collaboration with cross-functional teams and staying informed about industry trends will be key to delivering software solutions that meet business needs.
Primary Duties:
Perform all work in compliance with company quality procedures and standards.
Lead projects as assigned with minimal supervision by coordinating, directing, and coaching cross functional team members. While advocating for Software Quality, Security, and Agile best practices.
Act as a subject matter expert on CFR Part 11 requirements and Computer System Validation (CSV) and represent the needs of the Site for globally deployed computer systems.
Attend Non-Product Software Change Control Board (CCB) meetings and advise cross functional team members for planning validation/re-validation, change management and decommissioning of NPSW systems. Lead NPSW risk assessment efforts as needed.
Participate in Change Control Board (CCB) meetings as a non-product software QA representative. Support CAPA, investigations, NCs, Waivers as QA function. Revise and update validation SOPs and Site Validation Master Plan as required.
Author/review software and design history file required documents from a Quality oversight perspective.
Review and approve validation documentation ensuring conformance to site and global procedures as well as ISO, QSR, GXP, and/or GAMP regulations.
Lead software verification an d validation activities for development products including review and approval of software test case protocols and reports,... For full info follow application link.