We are recruiting for a Design History File Expert for my medical device client on a contract basis. You will be supporting technical activities within the development of parenteral drug delivery systems (combination devices) such as pre-filled syringes and injections.
* Ensure product compliance for the assigned projects
* Compile Design Control documentation and contributing to a high quality Design History file.
* Establishes/Participates in the documentation strategy
* Support of development of Quality Assurance Agreements with third parties.
* Bachelor’s or Masters in Engineering with at least 5 years of experience in a similar area
* Pre-filled-syringe device development, from early phase activities up to commercialization and production scale-up;
* Medical device quality assurance;
* DHF compilation, including Design Control process and other applicable regulatory, QA and GMP aspects;
* Understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive);
* Background in mechanical engineering in general
* Product design/Design for manufacture
* Test and verification, incl. development of methods and equipment
* Experience in medical device quality assurance;
* Good communication and conflict solving skills;
* Good technical knowledge in primary containers, e.g. syringes and cartridges;
* General understanding of pharmaceutical development ;
* General understanding of Human Factors Engineering and Risk management.
Kontakt: luchele.mendes (at the rate of) mbaswitzerland.com or call +41 (0) 44 215 2051
Michael Bailey International is acting as an Employment Business in relation to this vacancy.