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Systems Quality Engineer

Job Overview

Own the lifecycle management, validation, and sustained operation of digital quality systems and related capabilities. Serve as the Quality subject-matter expert and system owner for digital quality technologies, ensuring solutions are compliant, fit for purpose, inspection-ready, and aligned with cGMP, data integrity, and electronic records/electronic signatures…

Key points

  1. ​​Lead Quality ownership of digital quality systems, including implementation, enhancement, lifecycle management, and operational support for quality-related capabilities.

  2. ​Act as the Quality system subject-matter expert, translating business, cGMP, data integrity, and electronic records/electronic signatures requirements into clear system requirements and operational controls.

  3. ​Partner with Quality, Manufacturing, IT, Engineering, Validation, and other stakeholders to define, configure, test, deploy, and sustain compliant digital solutions.

  4. ​Own or coordinate Quality input to software and computer system validation activities, including risk assessments, requirements, test strategy, test execution, traceability, defect resolution…

  5. ​​Bachelor’s degree in engineering, computer science, life sciences, or a related technical discipline; advanced degree preferred.

  6. ​Experience with quality management systems, electronic records systems, manufacturing or laboratory systems, or comparable GxP digital platforms strongly preferred.

  7. ​Experience with software or computer system validation, including risk-based validation, requirements, testing, traceability, and validation documentation, preferred…

  8. ​Excellent written and verbal communication skills, with the ability to develop clear procedures, training, and inspection-ready documentation.

Skills

Stakeholder ManagementRisk ManagementCommunication

Experience: Entry-level · 5+ years · Job type: Full-time