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Software Quality Assurance Engineer
2 mesi fa
Position Overview
Agilent is dedicated to fostering innovations that enhance the quality of life. We supply life science, diagnostic, and applied market laboratories globally with instruments, services, consumables, applications, and expertise. A key mission at Agilent is to empower our clients with confidence in the integrity of their DNA, RNA, or protein samples across sectors such as Biopharma, Clinical Research, and Biotechnology. Utilizing advanced automated technology for various sample throughputs, alongside a diverse range of assays and kits, Agilent systems facilitate precise, efficient, and dependable quality control for numerous applications, including IVT mRNA, next-generation sequencing (NGS) libraries, cell-free and genomic DNA testing, as well as PCR fragment analysis.
About Agilent
With a workforce exceeding 18,000 employees across Europe, the Americas, and Asia Pacific, Agilent's global presence encompasses sales offices, logistics centers, business facilities, and manufacturing sites, enabling us to deliver high-quality solutions to our clientele in 110 countries. This opportunity is situated within the Diagnostics & Genomics Group (DGG).
Role Responsibilities
The selected candidate will join the Design Quality Group, which operates in both Germany and the US. As a Software Design Quality Specialist, you will provide guidance and expertise in product development and change control to R&D, marketing, procurement, and production teams. Your role will ensure the quality of data, products, and processes while overseeing design controls, risk management, and verification and validation activities related to our software solutions. Key responsibilities include:
- Supporting and engaging in new software product developments.
- Ensuring adherence to Agilent's quality management system throughout the product lifecycle.
- Participating in project meetings, design reviews, and risk management activities.
- Reviewing design history files and associated documentation.
- Overseeing the development of software testing strategies, including test scope and depth.
- Assisting in the creation and maintenance of test automation and regression test suites.
- Collaborating with R&D teams on data and information requirements, including compliance and security aspects.
- Defining metrics to evaluate various software attributes such as size, complexity, code coverage, and system performance.
- Providing input for verification and validation studies.
- Reviewing and approving design control deliverables and changes.
- Acting as a subject matter expert for software defects or critical issues impacting health and safety.
- Ensuring compliance with ISO 9001, ISO 13485, FDA CFR 21 Part 820, ISO 14971, and IEC 62304.
- Driving quality compliance projects and continuous improvement initiatives.
- Supporting audits and providing guidance or training to project teams on procedures, design verification, validation, statistical methods, and design controls.
Qualifications
Education
A Bachelor's or Master's degree in software engineering, business informatics, or a related field is preferred.
Experience
A minimum of 4 years of relevant experience in product development and/or quality engineering, utilizing both waterfall and agile methodologies (Scrum, Kanban). Experience with ISO 9001, ISO 13485, and ISO 62304, as well as relevant cybersecurity standards and data integrity compliance, is essential. Hands-on experience with test automation infrastructure and coding languages such as TypeScript, C#, JavaScript, Python, and VB Script is preferred. Familiarity with system architecture designs, including embedded systems, client-server, n-tier, web, and teamwork platforms is advantageous. A solid understanding of software project lifecycles, testing processes, and tools like JIRA is required. ISTQB Certification is a plus. Experience with laboratory equipment in the genomics field and knowledge of quality requirements for medical devices and data integrity compliance is preferred. The ability to work with multinational and interdisciplinary teams in a matrix organization is essential, along with strong planning and communication skills.
Additional Information
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.
Travel Requirements
Occasional travel may be required.Schedule
Full-time position.Shift
Day shift.Job Function
Quality/Regulatory.