Design Control Specialist, Intermediate
About The Position
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. Often entails problem solving the best way to document design controls for new projects with unique challenges.
Requirements
- Bachelor’s degree (BS) or advanced degree in biological sciences
- Minimum 3+ years relevant experience (product development/assay development/IHC/ISH)
- Strong writing skills
- High attention to detail
- Presentation skills (internal and external)
- Excellent communication and teamwork
- Ability to work independently
Nice To Haves
- Understanding of design control regulations and documentation requirements
- Knowledge in: Immunohistochemistry
- In situ hybridization
- Cell biology
- Molecular biology
- Experience in the diagnostics industry
Responsibilities
- 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, Verification & Validation (V&V) plans, requirement traceability matrices, etc.
- Maintaining Design & Development File (DDF) 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
Benefits
- Eligibility for bonus
- Eligibility for stock
- Eligibility for benefits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
