QA Specialist - Design Control (12 month temporary position)

Responsibilities

• Review and approve newly created or updated documentation
• Develop, maintain, and share best practice examples
• Drive continuous improvement in design documentation processes
• Primary areas of focus
• Device description
• Product requirements
• Design outputs specifications
• Product performance evaluation
• Product stability
• Labelling
• Regulatory submission files such as SSP and GSPR
• Post-market surveillance
• Quality and change plans
• Additional design history file (DHF) documentation

Requirements

• Master's degree in Biochemistry, Engineering, or related field of study.
• Preferably 2+ years of experience in design control within medical devices or in vitro diagnostics.
• Preferably 2+ years of experience in Quality Assurance.
• Perhaps knowledge of the compliance standards ISO 13485, ISO 14971, and IVDR.
• Full fluency in English. Fluency in Danish is not required but preferable.
• On a personal level, you are process and detail oriented, proactive and have great interpersonal skills.
• Join Us in Making a Difference
• If you're ready to apply your expertise in design control and quality assurance to help shape the future of diagnostic solutions, we look forward to hearing from you.
• Apply today and help us make an impact that matters.
• Additional Details
• This job has a full time weekly schedule.
• Travel Required:
• No
• Shift:
• Day
• Duration:
• 9-12 Months
• Job Function:
• Quality/Regulatory

Additional Information

Job Description Quality Assurance (QA) Specialist to IVDR technical files Make a global impact in cancer diagnostics - Join us at Agilent Are you passionate about making a difference in cancer diagnostics? Do you have experience with design control of medical devices? If so, we'd love to hear from you. At Agilent, we inspire and support discoveries that improve quality of life. We equip life science, diagnostic, and applied market laboratories around the world with instruments, services, consumables, applications, and deep scientific expertise. Our solutions empower our customers to find answers that help them do what they do best-make the world a better place. Learn more at www.agilent.com. At our Glostrup site, we specialize in developing and manufacturing reagents for in vitro cancer diagnostics. In our mission to deliver trusted answers, we are currently strengthening our readiness for the EU In Vitro Diagnostic Regulation (IVDR). As part of this growth, we are looking to add a QA Specialist to our dedicated IVDR QA team, currently composed of five skilled professionals. The IVDR QA team is responsible for managing design documentation for products currently on the market. We provide quality support for reagent devices and play a key role within the Quality Assurance department, upholding the highest standards in compliance and product quality. In this role, you will play a key part in supporting the IVDR transition for legacy products, ensuring full compliance with both regulatory requirements and internal quality procedures.

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