Design Quality Assurance (m/f/d) - IVD

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. Want more information on Agilent? Check out www.agilent.com!

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 groundbreaking 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.

About the organization

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 Life Sciences and Diagnostics Markets Group (LDG).

About this position

This position will become part of the Design Quality Group in 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

We offer:

• Permanent contract at our Waldbronn office (hybrid), close to Karlsruhe, in a fast-growing global company
• Competitive compensation and benefits package (yearly company bonus, private health care, pension scheme, discounted stock purchase plan, medical & life insurance…)
• Exciting projects in a dynamic collaborative team grounded on an agile culture
• Career development opportunities in an international company
• Work-Life-Balance is encouraged

Additional Details

This job has a full time weekly schedule.

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 available at: https://careers.agilent.com/locations

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.Travel Required: OccasionalShift: DayDuration: No End DateJob Function: Quality/Regulatory