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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 serve life science, diagnostic, and applied market laboratories globally with advanced 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 state-of-the-art automated technology for diverse sample throughputs and a wide array 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 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 customers in 110 countries. This opportunity is situated within the Diagnostics & Genomics Group (DGG).
Role Description
The successful candidate will join the Design Quality Group, which operates in both Germany and the US. As a Software Design Quality Specialist, you will offer guidance and expertise on product development and change control to R&D, marketing, procurement, and production teams. Your responsibilities will include ensuring data, product, and process quality while overseeing design controls, risk management, and verification and validation activities related to our software solutions. You will review software documentation and test results, including deviations and defects, and proactively implement corrective actions for product modifications. Additionally, you will ensure compliance with Agilent's quality management system and external standards, such as those applicable to medical device software development and cybersecurity. This role will involve providing quality oversight for a combination of research use only products and in-vitro diagnostics, necessitating collaboration with Agilent employees in Europe and the US.
Key Responsibilities
- Engage in and support new software product developments.
- Ensure adherence to Agilent's quality management system throughout the product lifecycle.
- Participate in project meetings, design reviews, risk management activities, and design transfers.
- Review design history files and related design documents.
- Oversee and assist in developing the software testing strategy, including test scope and depth.
- Support the creation and maintenance of the test automation and regression test suite.
- Assist R&D teams with data/information requirements, focusing on compliance and security aspects.
- Define metrics to evaluate various software attributes, such as size, complexity, code coverage, and system performance.
- Contribute 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 impacting health and safety.
- Ensure compliance with ISO 9001, ISO 13485, FDA CFR 21 Part 820, ISO 14971, and IEC 62304.
- Drive quality compliance initiatives and continuous improvement activities, including Kaizen, PDCA, and Six Sigma.
- Support audits and provide guidance or training to project teams on procedures, design verification and 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/or 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 such as JIRA is expected. ISTQB Certification is preferred, along with experience in laboratory equipment within the genomics field and the ability to communicate effectively regarding biological and clinical applications.
Experience with quality requirements for medical devices and data integrity compliance (21 CFR part 11, ISO 13485) is beneficial. Candidates should have experience working with multinational and interdisciplinary teams in a matrix organization, demonstrating pragmatism, flexibility, and a solution-oriented approach.
Strong planning and communication skills are essential, along with the ability to make independent decisions within organizational guidelines. Familiarity with good documentation standards and proficiency in providing technical guidance in English are required. A good understanding of statistical methods is preferred.
Travel Requirements
Occasional travel may be necessary.Schedule
Full-time position.Shift
Day shift.Duration
No end date.Job Function
Quality/Regulatory