Scientist - Design Control Documentation

Scientist - Design Control Documentation

Agilent Technologies

Glostrup, Denmark

Job Description:

We are seeking a highly motivated and detail-oriented scientist for Design Control Documentation. The successful candidate will focus on the design control documentation of medical devices for diagnostic use within the fields of tissue-based pathology assays such as immunohistochemistry.

Key Responsibilities:

• Develop, review, and maintain design control documentation in compliance with regulatory requirements, such as writing Design Input and Output documentation, Production Transfer documentation, protocols and reports including data analysis for stability, verification and validation studies of antibody assays for diagnostic use;
• Collaborate with cross-functional teams to ensure documentation accuracy and completeness;
• Support the design and development process by providing expertise in documentation standards and practices;
• Ensure timely updates and revisions of documentation as needed.

Qualifications:

• Master's degree or higher in a relevant field (e.g., Biochemistry, Biomedical Engineering, or related discipline);
• Experience with design control documentation in the medical device industry;
• Knowledge of regulatory requirements and standards (e.g., ISO 13485, FDA 21 CFR Part 820);
• Familiarity with immunohistochemistry and ISH/FISH molecular assays is highly desirable;
• Strong attention to detail and excellent organizational skills;
• Ability to work independently and as part of a team;
• Excellent written and verbal communication skills in English.