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. Information about Agilent is available at www.agilent.com
We are seeking a highly motivated and detail-oriented Design Control Documentation Specialist for a time-bound position of 18 months. The successful candidate will focus on the design control documentation of medical devices within the fields of immunohistochemistry and flow cytometry.

QUALIFICATIONS

• Master’s degree or higher in a relevant field (e.g., Biochemistry, Biomedical Engineering, or related discipline).
• Experience with design control documentation in the medical device industry.
• Knowledge of regulatory requirements and standards (e.g., ISO 13485, FDA 21 CFR Part 820).
• Familiarity with immunohistochemistry and flow cytometry is highly desirable.
• Strong attention to detail and excellent organizational skills.
• Ability to work independently and as part of a team.
• Excellent written and verbal communication skills in English.

• Develop, review, and maintain design control documentation in compliance with regulatory requirements, such as writing protocols and reports including data analysis for stability, verification and validation studies.
• Collaborate with cross-functional teams to ensure documentation accuracy and completeness.
• Support the design and development process by providing expertise in documentation standards and practices.
• Ensure timely updates and revisions of documentation as needed.
  About Our Team: The Reagent Design team is part of the New Product Introduction R&D department. We are a team of 11 employees skilled in design control documentation of clinical devices within the fields of immunohistochemistry and flow cytometry. Our team is dedicated to excellence and innovation in medical diagnostics.
  Work Environment: We cultivate a collaborative and supportive work environment where teamwork and cross-functional collaboration are highly valued. This approach not only enhances creativity but also ensures that everyone feels valued and supported in their roles.