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QA Design Control Specialist (d/f/m) (DE)

[5178]
21CFR820FDA

Our client is one of the leading companies when comes to develop and market autoinjectors and pen injectors for pharmaceutical applications. Founded in 1920 and with today 240 employees our client has built a solid company that is moving into the future with dynamic and highly motivated teams. Take a look at your next step as a Quality Assurance Specialist (m/f/d) Design Control  Your tasks ·QA partner of the development team for autoinjectors and drug/device combination products ·Ensuring regulatory and normative compliance during product development and life cycle management ·Support engineering and QA functions at the manufacturing sites to develop assembly, QC and batch documentation ·Review test strategy, tests plans and test reports, including stability testing and infrastructure qualification ·Review and approval of documentation provided by contractors and development partners ·Creation, review and approval of development / DHF documentation and support for the RA function in developing the documentation for regulatory submissions ·Customer communication regarding quality relevant topics Your qualifications ·Degree in technical engineering, ideally in the field of medical devices / biomedical engineering ·Several years experience in development / life cycle projects of medical devices or similar combination products in medical device and/or pharma industry ·Solid knowledge of the relevant standards and regulations both for medical devices and GMP, in particular ISO 13485, 21 CFR 210/211, 820 and the EU GMP guidelines ·Technical, social and methodical competence, combined with a hands-on mentality ·Precise and fact-oriented communication ·Very good command of written and spoken English and German If you feel attracted by this job feel free to get in touch with Tilman Grumbd, Managing Partner at Optares Medical via tilman.grumbd@optares.de or by phone under 0049 441 218 7934

Our client is one of the leading companies when comes to develop and market autoinjectors and pen injectors for pharmaceutical applications.

Founded in 1920 and with today 240 employees our client has built a solid company that is moving into the future with dynamic and highly motivated teams.

Take a look at your next step as a

Quality Assurance Specialist (m/f/d)
Design Control 

Your tasks
  • QA partner of the development team for autoinjectors and drug/device combination products
  • Ensuring regulatory and normative compliance during product development and life cycle management
  • Support engineering and QA functions at the manufacturing sites to develop assembly, QC and batch documentation
  • Review test strategy, tests plans and test reports, including stability testing and infrastructure qualification
  • Review and approval of documentation provided by contractors and development partners
  • Creation, review and approval of development / DHF documentation and support for the RA function in developing the documentation for regulatory submissions
  • Customer communication regarding quality relevant topics

Your qualifications

  • Degree in technical engineering, ideally in the field of medical devices / biomedical engineering
  • Several years experience in development / life cycle projects of medical devices or similar combination products in medical device and/or pharma industry
  • Solid knowledge of the relevant standards and regulations both for medical devices and GMP, in particular ISO 13485, 21 CFR 210/211, 820 and the EU GMP guidelines
  • Technical, social and methodical competence, combined with a hands-on mentality
  • Precise and fact-oriented communication
  • Very good command of written and spoken English and German

If you feel attracted by this job feel free to get in touch with Tilman Grumbd, Managing Partner at Optares Medical via tilman.grumbd@optares.de or by phone under 0049 441 218 7934

map Stuttgart, Deutschland date_range 05.11.2021 update Permanent
Qualitätswesen Qualitätssicherung Quality Assurance Medizintechnik 21CFR820FDA


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