QA Engineer 2 - Software Systems

Overview

The Quality Engineer II - Software Systems supports the Quality Management System by ensuring compliance of computerized systems, electronic records, and manufacturing software applications with regulatory requirements and company procedures.

Responsibilities

• Serve as the Quality representative for software and computerized system validation activities across manufacturing and quality operations.
• Ensure robust software validation practices are applied across all departments, ensuring that software systems impacting product or process quality are developed, validated, and documented in compliance with regulatory, quality system, and technical requirements.
• Review and approve all deliverables associated with software validation-including validation plans, URS, functional specifications, risk assessments, IQ/OQ/PQ protocols, traceability matrices, and validation reports-to verify compliance with global policies and regulatory standards.
• Provide guidance on software lifecycle processes, including equipment with software, software only systems, and spreadsheet validations, and ensure new or updated software systems are assessed and qualified through Dexcom change control processes.
• Control, document, and address discrepancies and deviations in software qualification projects; support software related nonconformance events, investigations, and CAPA activities.
• Provide software validation, Part11, and data integrity guidance in accordance with SOPs, industry and regulatory standards.
• Support data integrity initiatives, audit trail reviews, system access reviews, and electronic record compliance assessments.
• Lead or support impact assessments, risk assessments, investigations, root cause analyses, and CAPA activities related to software.
• 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 (FDA, ISO13485, BSI, MDSAP).
• Collaborate with global teams to support project implementation and compliance objectives, 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 compliance, data integrity, and quality system requirements.
• Assist in mentoring junior engineers and developing 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.

Qualifications

• Strong understanding of computerized system validation (CSV) and Computer Software Assurance (CSA) principles and software lifecycle management.
• Knowledge of 21CFR Part11 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.
• 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.

Experience and Education

• Bachelor's degree in engineering, quality, or a related field.
• At least 3 years of experience in a regulated industry.
• Knowledge of ISO13485, 21CFR Part11, and 21CFR820.
• 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.

Travel

0-5% travel.