Software Quality Engineer II

Goal of Function:

This role will support the validation of computerized systems within the Quality Management and Regulatory Systems department, ensuring compliance with regulatory requirements and industry standards. This position requires knowledge and experience with TrackWise, IQVIA SmartSolve, and Quality Management Systems (QMS).

Tasks & Responsibilities:

System Support:

• Respond to and resolve support tickets for TrackWise, IQVIA SmartSolve, and other QMS-related software.
• Provide technical assistance and troubleshoot issues for end-users.
• Monitor and ensure that key performance indicators (KPIs) related to ticket response time, ticket resolution time, first contact resolution rate, ticket reopen rate, customer satisfaction score, and number of tickets handled are consistently met.

Computerized System Validation:

• Creates and/or updates validation deliverables including but not limited to validation assessments, validation plans, test plans, test protocols, test reports, validation summary reports, and trace matrices, as needed to support computerized system implementation in a regulated environment.
• Execute and review test protocols to support computerized system implementation in a regulated environment.
• Collaborate with business owners and IT teams to define and document business requirements, functional specifications, and system specifications.

Compliance and Quality Assurance:

• Ensure that validation deliverables are of high quality and compliant with FME policies/procedures.
• Support regulatory audits and inspections as a Subject Matter Expert.

Computerized System Validation Documentation:

• Compiles and maintains approved project deliverables.

Communication:

• Communicate project and compliance issues to management.
• Escalate issues to supervisor/manager when necessary.

Guidance and Training:

• Provide guidance to external contractors working on computerized system validation projects.
• Train end-users on validated systems and procedures related to the computerized system.
• Assist in the development of training materials and programs.

Compliance and Quality Assurance:

• Partner with business teams and IT to ensure that computerized systems are compliant with internal FME procedures, and regulations or guidelines, e.g., but not limited to FDA Quality System Regulations, 21 CFR Part 11, and GAMP5.

Education & Experience:

• Bachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, or a related field, or successfully completed a technical apprenticeship supplemented with appropriate professional experience in a comparable role
• Must be knowledgeable about FDA electronic records and electronic signature requirements, and all GAMP 5 software validation requirements
• Minimum 1 – 2 years of experience in software engineering, information technology, or software quality assurance in a regulated environment; with an advanced degree no prior experience may be acceptable.
• Familiarity with TrackWise, IQVIA SmartSolve, and other Quality Management Systems (QMS).
• Understanding of regulatory requirements (FDA, ISO 13485) and Good Automated Manufacturing Practice (GAMP5).
• Experience in creating validation deliverables such as validation plans, test protocols, test reports, and validation summary reports.
• Execution of test protocols and independent review of test executions.
• Participation in regulatory audits and inspections, preferably as a Subject Matter Expert for validation projects.
• Documentation management, ensuring compliance with internal policies and regulatory requirements.
• Providing technical support for QMS-related software and collaborating with business owners and IT teams to define business and system requirements.
• Training end-users on validated systems and associated procedures.
• Continuous improvement initiatives, identifying opportunities for process enhancement within validation methodologies.
• Shows a strong work ethic by staying motivated, thinking systematically, and using analytical approaches.
• Is detail-oriented, with excellent communication and project management skills, and is committed to achieving goals.
• Values teamwork and builds positive relationships across teams.
• Understands and respects cultural differences, navigating international settings effectively.
• Communicates effectively both verbally and in writing.
• Adapts well to changes in business strategy or shifting priorities.
• Works well in teams and with others, demonstrating strong interpersonal skills.
• Trackwise, IQVIA SmartSolve or other QMS expertise, administrative and support level knowledge
• GAMP 5 software validation knowledge
• 21CFR Part 11 e-signature knowledge
• high language proficiency in English
• German as a benefit
• Relevant experience with Quality system IT Platforms – specifically Trackwise, IQVIA SmartSolve
• Knowledge of computerized software validation and computer software assurance principals
• Knowledge and understanding of business systems, Windows Office, Teams, Projectplace, Visio etc
• Strong knowledge of Medical Devices Data models, processes and system.
• Basic familiarity with the production of dialysis products
• Willingness to be on site in Bad Homburg as needed
• Willingness to travel within Europe and in the US as needed to support projects.