Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied chemical 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. .
Are you passionate about Antibody development and Change Control, as well as wanting to make a difference in cancer diagnostics worldwide?
Agilent is a global leader in tissue-based cancer diagnostics. Hospital and research laboratories worldwide use Agilent’s Dako reagents, instruments, software and expertise to make precise diagnoses and determine the most effective treatment for cancer patients.
Join us and become our new QA specialist in the Design Assurance Reagent team, where we ensure Agilent delivers safe and secure IVD classified reagents to the marked of cancer diagnostics.
You will be responsible for the quality of our reagents solutions by facilitating Reagent development and Change control activities including Risk Management according to the regulations of the MDSAP members, China and Korea.
The Design Assurance Reagents Team is part of the department Quality Engineering and comprise 10 dedicated QA specialist and a QA coordinator. The team supports our Research and Development organization and Marketing team in relation to new product introduction, risk management activities, product changes, product care meetings and quality plans.
You will be responsible for QA input, review and approval of:
- Change Requests
- Change implementation
- Design Transfer
- Stability Studies
- IVDR Tech files
Reviewing Change Requests to right level of quality requires familiarity with:
- Product Requirements
- Risk management
- Human factors engineering
- Design verification
- Design validation
In addition, one of the major task of the team for the coming year is getting the documentation for our current reagent portfolio ready for IVDR submission. Knowledge of IVDR is therefore an advantage.
- Academic degree in Engineering, Biochemistry or related field of study.
- +10 years of experience from a Quality Assurance function.
- + 5 years of experience with Change Control and Design transfer within Medical Devices.
- In-depth knowledge of ISO13485, FDA CFR 21 Part 820 and ISO14971.
- Proficiency in written and spoken English.
To be successful in the role you must have excellent communication and collaboration skills, enjoy working in project teams and take pride in delivering high quality documentation at scheduled time. Furthermore, it is important that you can structure work from several projects, are open minded and thrive in a continuously developing environment.
A job among highly qualified and committed colleagues taking pride in making a difference in a company, where the products truly impact people-s life.
An open, fun, and inclusive work environment, where we care for one another.
If you have any questions to the position – please contact Hiring Manager, Brian Jensen on +45 5167 6381.
Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.
No End Date