Design Quality Assurance - Genomics Products

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 enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us.

One of our missions at Agilent is to enable our customers to make new discoveries in the genomics field by providing array-based and Next Generation Sequencing workflow products as well as to gain genetic insights that can be used for pre- and postnatal diagnosis. With groundbreaking automated technology for library preparation and target enrichment, Agilent systems enable accurate, efficient, and reliable genomic application of various range and depth.

About this position

This position will become part of the Design Quality Group and will be located in Santa Clara or La Jolla, California. In this role, you will provide guidance and expertise on IVD and RUO product development and change control to R&D, marketing, procurement and production. You 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 new product solutions. The successful candidate will review documentation and test results, including deviations, 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, especially IVDR. 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. The successful candidate will support projects for software, assay and hardware development.

Key Responsibilities

• Support and engage in IVD and RUO product developments, specifically for assays, software and hardware in genomic applications

• Ensure compliance to Agilent’s quality management system as part of the product lifecycle including the review of design history files and associated design documents

• Participate in project meetings and design reviews, risk management activities, design transfer, etc.

• Co-design and provide guidance on IVD performance studies in close cooperation with R&D engineers, molecular biologists and chemists as well as marketing and support stakeholders

• Support R&D teams on data/information requirements including compliance and security aspects

• Build IVD risk files for products and/or processes

• Ensure compliance with ISO 9001, ISO 13485, ISO 62366, ISO 62304, FDA CFR 21 Part 820 and ISO 14971

• Drive quality compliance projects and continuous improvement activities such as Kaizen, PDCA and Six Sigma

Qualifications

• Bachelor’s in scientific fields (molecular biology, biochemistry, chemistry) or engineering (chemical engineering, bioengineering)

• 4+ years' of experience in the areas of IVD and/or RUO product development and/or quality engineering

• Quality assurance experience for IVD instruments, assays and/or software under ISO 13485, 14971, 62366 and 62304

• Work experience in developing chem/bio-based applications including exposure to DoE, FMEA and MSA activities

• Experience with laboratory equipment in the genomics field preferred with the ability to communicate and understand biological and clinical applications

• Experience in gap assessments and remediations

• Experience with software development preferred

• Strong communication skills and experience providing technical guidance

• Proficient in managing personal workload effectively amidst shifting priorities

• Experience with multi-national and interdisciplinary teams in a matrix organization

• Familiar with good documentation standards

Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least September 2, 2025 or until the job is no longer posted.

The full-time equivalent pay range for this position is $104,774.00 - $183,600.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are av