Software Quality Engineer

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:

1. Perform all work in compliance with company quality procedures and standards.
2. 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.
3. 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.
4. 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.
5. 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.
6. Author/review software and design history file required documents from a Quality oversight perspective.
7. Review and approve validation documentation ensuring conformance to site and global procedures as well as ISO, QSR, GXP, and/or GAMP regulations.
8. Lead software verification and validation activities for development products including review and approval of software test case protocols and reports, software development plans, and other system and software documentation required to establish software requirements.
9. Perform risk evaluation and associated activities related to software development including FMEA, product risk analysis, and mitigation.
10. Identify and implement improvements to the Quality Management System, validation master planning, software development lifecycle and testing practices within the company. Develop policies for management and assessment of non-product software releases.
11. Execute quality event initiation, investigation, and closure for nonconformance's, CAPA, change control, Risk Analysis, FMEA, and complaints. Perform effectiveness checks.
12. Define and monitor key metrics for the QA process, ensuring continuous improvement and prepare and present detailed reports on QA activities, test results, and quality metrics to stakeholders
13. Work closely with cross-functional teams, including Product/Project Managers, Quality Assurance (QA), Engineers, and other Stakeholders, to understand requirements and deliver software solutions that meet business needs.
14. Participate in and conduct code reviews to ensure code quality, adherence to coding standards, and knowledge sharing within the team.
15. Support FDA and MDSAP Audits as well as Supplier and Internal Audit initiatives.
16. Stay informed about industry trends, new technologies, and best practices. Apply new knowledge to improve existing systems and processes.
17. May train associates and/or contractors as needed.
18. Performs other duties as assigned.

Education/Experience:

1. Requires a bachelor's degree in Life Science, Computer Science, Software Engineering, or other equivalent discipline.
2. 10 years relevant experience will be accepted in lieu of degree in Life Science, Computer Science, Software Engineering, or other equivalent discipline.
3. Minimum time and type experience required for this position.
   • 5 years minimal experience with Computerized System Validation Lifecycle and/or Software Quality Assurance.
   • Certified Software Quality Engineer (ASQ) preferred.

Knowledge/Skills/Abilities:

1. Requires strong self-motivation/proactive, organizational skills, risk management capabilities, and how to work collaboratively in a team environment
2. Competence in Medical Device Development Processes and/or Computer System Lifecycle Validation Compliance demonstrated by relevant industry experience in Medical Device or other FDA regulated industry.
3. Competence in the interpretation and application of relevant Domestic and International Regulations, Standards, and Guidances to provide input for computerized systems and/or automated business processes. Demonstrated by relevant experience in Medical Device or other FDA regulated industry.
4. Requires strong debugging and troubleshooting skills to identify the root cause of issues quickly in complex software systems.
5. Requires strong computer skills including Microsoft Suite Package (Excel, Word, etc.).
6. Requires effective written and verbal communication skills. Ability to communicate effectively across all levels of management including executive level. As well as strong Technical Writing capabilities.
7. Knowledge of Software Development Life Cycle (SDLC).

Physcial Requirements:

• Ability to remain in a stationary position, often standing, for prolonged periods.
• Domestic travel required <10%