CDx Design Control Specialist, Intermediate

Company: Agilent
Location: Carpinteria
Posted on: October 11, 2021

Job Description:

As a healthcare company committed to protecting the health and safety for our employees, contractors, customers and communities, employees in this role are required to be fully vaccinated against COVID-19, unless an accommodation has been granted for a medical reason or sincerely held religious belief.

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.

This position is in Agilent’s Companion Diagnostics (CDx) division and supports development of precision medicine diagnostic devices for oncology therapies. The Design Control Specialist will work closely and collaboratively with specialists in R&D, project management, clinical affairs, regulatory affairs, manufacturing and quality assurance teams to guide the development of high-quality companion diagnostic products by planning and executing design control processes and strategies as part of our Quality Management System. Innovative ideas and excellent performance will bring value for Agilent and contribute to treating cancer.

Key responsibilities include:

• Ensuring the successful design and development of new products through collaboration with cross-functional teams
• Supporting development of design control records including design and development planning, risk management files, V&V plans, requirement traceability matrices, etc.
• Maintaining Design History File (DHF) and ensuring its accuracy
• Coordinating and leading design review meetings and design changes
• Contributing to and maintaining the risk management file with input from development teams
• Identifying and implementing process improvements to establish standardized best practices
• Working across Agilent divisions to draft and provide input to Agilent global documentation and processes
• Supporting and contributing to internal and external audits
• Working on problems of diverse scope, ensuring alignment and consistency wherever possible
• Exercising judgment within generally defined practices and policies to problem-solve when faced with complex challenges

This can be a remote position- it does require on-site presence for certain tasks

Keywords: Agilent, Santa Barbara , CDx Design Control Specialist, Intermediate, Other , Carpinteria, California