Agilent
Healthcare
DesignControlSpecialist,Intermediate
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Design Control Specialist, Intermediate at Agilent. Skills: Design control, Quality assurance, Regulatory affairs. Ensure successful design and development. Support development of design control records”
What You'll Achieve.
Contribute to treating cancer
Industry & Context.
Problem solving
On-site presence for certain tasks, Occasional travel
What They're Looking For.
Must Have
Bachelor's degree (BS) or advanced degree in biological sciences, Minimum 3+ years relevant experience, writing skills, High attention to detail, Presentation skills (internal and external), Excellent communication and teamwork, Ability to work independently
Nice to Have
Understanding of design control regulations, Knowledge in Immunohistochemistry, Knowledge in In situ hybridization, Knowledge in Cell biology, Knowledge in Molecular biology, Experience in the diagnostics industry
What You'll Do.
Ensure successful design and development
Support development of design control records
Maintain Design & Development File (DDF)
Coordinate and lead design review meetings
Contribute to and maintain risk management file
Identify and implement process improvements
Draft and provide input to global documentation
Support and contribute to internal and external audits
Work on problems of diverse scope
Exercise judgment within defined practices
How You'll Work.
Team & Collaboration
Cross-functional teams; R&D; Project management; Clinical affairs; Regulatory affairs; Manufacturing; Quality assurance
Communication Scope
Presentation skills
Full 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** **Job Function** 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. **a) Organizational** Position has no reporting employees and reports to one direct manager. **b) Span of Control and Authority** Position requires the authority to draft documents, initiate workflows in Agile, and make changes necessary to support product development within the CDx R&D department. **c) Communication / Contacts** _Internal:_ Communicate with project managers, scientists, research associates within R&D and representatives from other departments (e.g. production, RA, QA, etc.) as required to aid in development of various CDx products. _External:_ No planned communication with external contacts (i.e. vendors, customers, etc.); however, communication with representatives from these groups may occur. For example, employee may be required to interacts with auditors perfo
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