QA Specialist - Design Control

Responsibilities

• Review and approve newly created or updated design documentation to ensure compliance.
• Support the IVDR transition for legacy medical device products through meticulous documentation management.
• Develop, maintain, and share best practice examples for design control processes.
• Drive continuous improvement in design documentation and quality procedures.
• Manage key focus areas including device descriptions, product requirements, design output specifications, and product performance evaluation.
• Oversee regulatory submission files such as SSP and GSPR, labeling, and post-market surveillance.
• Maintain Design History File (DHF) documentation, product stability, and quality/change plans.

Requirements

• Master’s degree in Biochemistry, Engineering, or a related field of study.
• 2+ years of experience in Quality Assurance.
• 2+ years of experience in design control within medical devices or in vitro diagnostics.
• Knowledge of compliance standards including ISO 13485, ISO 14971, and IVDR.
• Full fluency in English.
• Strong interpersonal, communication, and stakeholder management skills.
• Ability to manage multiple projects simultaneously in a detail-oriented and proactive manner.

Preferred Qualifications

• Fluency in Danish.
• Proven experience working within project teams in a continuously developing environment.

About the Company

Agilent is a global leader in laboratory and clinical technologies, dedicated to bringing great science to life. We equip life science, diagnostic, and applied market laboratories around the world with instruments, services, consumables, and deep scientific expertise. Our mission is to provide trusted answers that help our customers improve quality of life and make the world a better place.