Design Quality Assurance Position - IVD

Agilent Technologies

Waldbronn, Germany

In this role, you will provide guidance and expertise on IVD 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.

Key Responsibilities

Support and engage in IVD product developments, specifically for instruments and/or assays for automated laboratory equipment
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 and/or ISO 13485, FDA CFR 21 Part 820 and ISO 14971
Drive quality compliance projects and continuous improvement activities such as Kaizen, PDCA and Six Sigma

Qualifications

University degree in scientific fields (molecular biology, biochemistry, chemistry) or engineering (chemical engineering, bioengineering) or equivalent, Master or PhD preferred
Proficient years of experience in the areas of IVD product development and/or quality engineering
Quality assurance experience for IVD instruments and/or assays under ISO 13485
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
Strong skilled in exchanging communication and providing technical guidance in English, German skills are a plus
Experience with multi-national and interdisciplinary teams in a matrix organization
Good planning and communication skills
Familiar with good documentation standards

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