Software Design Quality Assurance Specialist

Job Description

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.

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 within Pathology/RP/CDx business division of the Diagnostics & Genomics Group (DGG) where we develop and produce reagents for in vitro diagnostic of cancer as well as instruments and software.

Position -

This position will become part of the Development QA Team which is located in Glostrup. 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.

As this position will be working closely with Agilent employees in Europe and the US, the candidate should be open to work flexible hours to meet and 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
• Review and approve design control deliverables and changes (ECR/ECO)
• Act as QA subject matter expert for software defects or critical issues affecting health/safety
• Ensure compliance with ISO13485, IEC 62304, FDA CFR 21 Part 820, ISO 14971, cybersecurity etc.
• Drive quality compliance projects and continuous improvement activities
• Support in audits
• Provide guidance and/or training to project teams on procedures, statistical methods, and design control activities.

Qualifications

EDUCATION

• Bachelor's or Master's degree in software engineering, business informatics or equivalent

EXPERIENCE/SKILLS

• +4 years of relevant experience in the areas of product development and/or quality engineering using waterfall and agile methodologies (Scrum, Kanban)
• Deep understanding of ISO 13485, ISO 62304, FDA CFR 21 Part 820, ISO 14971 as well as relevant cybersecurity standards and data integrity compliance.
• Hands-on-experience with test automation infrastructure
• Hands on experience with coding languages like Type Script, C#, JavaScript, Python, VB Script
• Experience with system architecture designs including embedded systems, client-server, n-tier, web and collaboration platforms
• Understanding of software project lifecycles, test processes and tools such as JIRA
• ISTQB Certification preferred
• Pragmatic, flexible and solution-oriented.
• Analytical skills with focus on finding the right solutions in compliance with regulations.
• Good planning and communication skills.
• Able to make independent decisions within guidelines of the organization.
• Experience with multi-national and interdisciplinary teams in a matrix organization
• 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. 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.

Option to Work Remote

Yes

Travel Required

10% of the Time

Schedule

Schedule:Full time

Shift

Day

Duration

No End Date

Job Function

Quality/Regulatory