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Design Control Specialist

Organization
Agilent
Job Location
7051 Eagle Blvd
Longmont, CO 80504
United States
Job Description

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.

The Design Control Specialist will work closely and collaboratively with specialists in R&D, project management, clinical science, 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 novel products through collaboration with cross-functional teams
  • Supporting development of design control records including risk management plans, V&V plans, requirement traceability matrices, etc.
  • Maintaining Design History File (DHF) 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 processes
  • Supporting and contributing to internal and external audits
  • Working on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for acquiring solutions

 

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

Requirements

Qualifications

  • University Degree (ideally in a scientific field) or equivalent experience
  • 2 + years proven experience
  • Demonstration of excellent communication and teamwork skills
  • Must have exceptional writing skills
  • Ability to communicate optimally with a cross-functional team
  • Proven ability to prioritize and work on multiple projects simultaneously

Preferred Qualifications:

  • 2+ years of experience in IVD/Medical Device or pharmaceutical product development (regulated industry)
  • Advanced degree in a scientific field
  • Previous Oracle or Agile experience preferred

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