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Design History Files Expert - Medical Devices
Eingestellt von Michael Bailey Associates - Munich
Gesuchte Skills: Design, Engineering
Projektbeschreibung
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.
Responsibilities:
- 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.
Requirements:
- 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, eg syringes and cartridges;
- General understanding of pharmaceutical development;
- General understanding of Human Factors Engineering and Risk management.
Kontakt: luchele mendes or call
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
You will be supporting technical activities within the development of parenteral drug delivery systems (combination devices) such as pre-filled syringes and injections.
Responsibilities:
- 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.
Requirements:
- 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, eg syringes and cartridges;
- General understanding of pharmaceutical development;
- General understanding of Human Factors Engineering and Risk management.
Kontakt: luchele mendes or call
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik