Software Quality Engineer

vor 1 Woche

Waldbronn, Deutschland Agilent Vollzeit

About the Role

Agilent is a leading life science, diagnostic, and applied market laboratory company that inspires and supports discoveries that advance the quality of life. We provide instruments, services, consumables, applications, and expertise to laboratories worldwide.

Job Summary

We are seeking a highly skilled Software Design Assurance Specialist to join our Design Quality Group. As a key member of our team, you will provide guidance and expertise on product development and change control to R&D, marketing, procurement, and production teams.

Key Responsibilities

  • Ensure data, product, and process quality and provide oversight of design controls, risk management, and verification and validation activities of our software solutions.
  • Review software documentation and test results, including deviations and defects, and take corrective actions for modification of products.
  • Ensure compliance to Agilent's quality management system and to external standards of medical device software development and cybersecurity.
  • Provide quality oversight to a mix of research use only products and in-vitro diagnostics.
  • Support and engage in new product developments of software.
  • Participate in project meetings and design reviews, risk management activities, design transfer, etc.
  • Review of design history files and associated design documents.
  • Oversee and support the development of the software test strategy, test scope, and test depth.
  • Support the development and maintenance of the test automation and regression test suite.
  • Support R&D teams on data/information requirements, including compliance and security aspects.
  • Define appropriate metrics to assess various software attributes, such as size, complexity, code coverage, and system performance.
  • Provide input to verification and validation studies.
  • Own, review, and approve design control deliverables and changes (ECR/ECO).
  • Act as a subject matter expert for software defects or critical issues affecting health/safety.
  • Ensure compliance with ISO 9001 and/or ISO 13485, FDA CFR 21 Part 820, ISO 14971, and IEC 62304.
  • Drive quality compliance projects and continuous improvement activities, such as Kaizen, PDCA, and Six Sigma.
  • Support in audits.
  • Provide guidance and/or training to project teams on procedures, design verification and validation, statistical methods, and design controls.

Requirements

  • Bachelor's or Master's degree in software engineering, business informatics, or equivalent.
  • 4 years of relevant experience in product development and/or quality engineering using waterfall and agile methodologies (Scrum, Kanban).
  • Work experience under ISO 9001, ISO 13485, and/or ISO 62304, as well as relevant cybersecurity standards and data integrity compliance.
  • Hands-on experience with test automation infrastructure.
  • Hands-on experience with coding languages, such as Type Script, C#, JavaScript, Python, VB Script.
  • Experience with system architecture designs, including embedded systems, client-server, n-tier, web, and teamwork platforms.
  • Understanding of software project lifecycles, test processes, and tools, such as JIRA.
  • ISTQB Certification.
  • Experience with laboratory equipment in the genomics field, with the ability to communicate and understand biological and clinical applications.
  • Experience in quality requirements for medical devices and data integrity compliance and workflows.
  • Experience with multi-national and interdisciplinary teams in a matrix organization.
  • Pragmatic, flexible, and solution-oriented.
  • Good planning and communication skills.
  • Able to make independent decisions within guidelines of the organization.
  • Familiar with good documentation standards.
  • Strong skills in exchanging communication and providing technical guidance in English.
  • Good understanding of statistical methods.

About Agilent

Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected categories under all applicable laws.

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