QA Engineer 2 - Software Systems

Meet the team:

The Quality Engineer II – Software Systems is responsible for supporting the Quality Management System by ensuring compliance of computerised systems, electronic records, and manufacturing software applications with regulatory requirements and company procedures. This role partners closely with Information Technology (IT), Quality, Manufacturing, Validation, and Regulatory Affairs to maintain compliant, validated systems while supporting operational excellence and continuous improvement initiatives.

The successful candidate will have experience with 21 CFR Part 11 compliance, computerised system validation (CSV), data integrity principles, and quality system processes within a regulated environment. This position plays a key role in ensuring software systems remain compliant, inspection-ready, and capable of supporting Dexcom's manufacturing and quality operations.

Where you come in:

• Serve as the Quality representative for software systems and computerised system validation activities across manufacturing and quality operations.
• Ensure that robust software validation practices are applied across all departments, such that software systems impacting product or process quality are developed, validated, and documented in compliance with established regulatory, quality system, and technical requirements, providing assurance of their intended use and performance.
• Review and approve all deliverables associated to Software Validation to ensure it is qualified to its intended use and is carried out in compliance with Global Policies and Regulatory Standards including but not limited to:
• o Validation Plans
• o User Requirements Specifications (URS)
• o Functional Specifications
• o Risk Assessments
• o IQ/OQ/PQ Protocols
• o Traceability Matrices
• o Validation Reports
• Provide guidance to teams on Software Lifecycle processes including but not limited to Equipment with Software, Software Only systems, Spreadsheet Validations.
• Ensures that all new Software Systems, and updates to existing Software systems are assessed and qualified according to established Dexcom Change Control processes.
• Ensures that all discrepancies and deviations encountered in Software Qualification projects
• are adequately controlled, documented, and addressed by the Project Team.
• Support software-related nonconformance events, investigations, and CAPA activities.
• Provides software validation/compliance/part 11/ data integrity guidance in accordance with policies, SOPs, industry and regulatory standards.
• Support data integrity initiatives, including audit trail reviews, system access reviews, and electronic record compliance assessments.
• Support or lead software-related impact assessments, risk assessments, nonconformances, investigations, root-cause analysis, and CAPA activities
• Develop, update, and maintain quality procedures and work instructions related to computerized systems and software validation.
• Perform periodic reviews of computerized systems to verify ongoing compliance and effectiveness.
• Support internal audits and external inspections including but not limited to FDA, ISO 13485, BSI, and MDSAP audits.
• Collaborate with Global Quality, IT, Manufacturing, Regulatory Affairs, and Validation teams to support project implementation and compliance objectives.
• Provide quality oversight and support for digital transformation, automation, and Smart Factory initiatives.
• Support supplier qualification and oversight activities for software vendors and service providers.
• Provide training and guidance to system users regarding software compliance, data integrity, and quality system requirements.
• Assist in mentoring junior engineers and supporting development of best practices within the quality organization.
• Communicate quality, compliance, environmental, health, and safety concerns to management in a timely manner.
• Perform other duties as assigned.
• What makes you successful:
• Strong understanding of computerized system validation (CSV) and Computer Software Assurance (CSA) principles and software lifecycle management.
• Knowledge of 21 CFR Part 11 requirements for electronic records and electronic signatures.
• Experience applying data integrity principles within a regulated environment.
• Ability to interpret regulatory requirements and translate them into practical business solutions.
• Strong analytical and problem-solving skills.
• Explain factual information of limited complexity to others in straightforward situations.
• Excellent written and verbal communication skills.
• Ability to collaborate effectively across multiple functions and global teams.
• Strong attention to detail and documentation practices.
• Demonstrated ability to manage multiple priorities and projects simultaneously.
• Continuous improvement mindset with a focus on compliance and efficiency.
• Minimum of 3 years with and/or equivalent experience, training
• Must work well in a team environment
• Good oral and written communication skills
• Self-starter with the ability to identify improvement opportunities
• Able to work independently under limited supervision as well as in a team environment

Travel Required:

• 0-5%

Experience and Education Requirements:

• Bachelor’s degree in engineering, Quality, or related field.
• At least 3 years of experience in a regulated industry.
• Knowledge of ISO 13485, 21 CFR Part 11, 21 CFR 820,
• Experience working on cross site or global system projects. Audit experience with FDA, BSI, or MDSAP.
• Experience with manufacturing systems, MES, ERP, or QMS applications. SQL experience for read only queries. Experience mentoring or training other engineers.