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Software Design Assurance Specialist
vor 2 Monaten
About the Role
Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. One of our missions at Agilent is to help our customers gain confidence in the quality of their DNA, RNA or protein samples in industries such as Biopharma, Clinical Research and Biotech. With cutting-edge automated technology for various sample throughputs, and a broad variety of assays and kits, Agilent systems enable accurate, efficient, and reliable quality control for multiple applications. Examples include IVT mRNA, next-generation sequencing (NGS) libraries, cell-free and genomic DNA testing as well as PCR fragment analysis.
About the Team
Agilent has over 18,000 employees spread across Europe, the Americas and Asia Pacific. Our global footprint includes sales offices, logistics centers, business facilities, and manufacturing sites that enable us to deliver high-quality solutions to our customers in 110 countries. There are 3 Business Groups within Agilent. This job opportunity is with the Diagnostics & Genomics Group (DGG).
About the Position
This position will become part of the Design Quality Group which is located both in Germany and the US. In this role, the software design quality specialist will provide guidance and expertise on product development and change control to R&D, marketing, procurement and production. The SW design assurance specialist will ensure data, product and process quality and will provide oversight of design controls, risk management as well as verification and validation activities of our software solutions. The successful candidate will review SW documentation and test results, including deviations and defects, and will proactively take corrective actions for modification of products. The role and responsibility further include ensuring compliance to Agilent's quality management system and to external standards of, for example, medical device software development and cybersecurity. The specialist in this role will provide quality oversight to a mix of research use only products and in-vitro diagnostics. As this position will be working closely with Agilent employees in Europe and the US, the candidate should be open to support global teams in relevant time zones.
Key Responsibilities
- Support and engage in new product developments of software
- Ensure compliance to Agilent's quality management system as part of the product lifecycle
- 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 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, 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
Qualifications
Education
Bachelor's or Master's degree preferred in software engineering, business informatics or equivalent
Experience
4 years of relevant experience in the areas of 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 preferred
Hands on experience with coding languages like Type Script, C#, JavaScript, Python, VB Script preferred
Experience with system architecture designs including embedded systems, client-server, n-tier, web and teamwork platforms preferred
Understanding of software project lifecycles, test processes and tools such as JIRA
ISTQB Certification preferred
Experience with laboratory equipment in the genomics field preferred with the ability to communicate and understand biological and clinical applications (Bioanalyzer, TapeStation, Fragment Analyzer, Gel or Capillary Electrophoresis or Liquid Chromatography)
Experience in quality requirements for medical devices and data integrity compliance and workflows preferred (21 CFR part 11, ISO 13485)
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 skilled in exchanging communication and providing technical guidance in English
Good understanding of statistical methods preferred
Agilent Technologies Inc. is an equal opportunity employer.
Travel Required
Occasional
Job Function
Quality/Regulatory
