Employee Quality Assurance Design Control - Stuttgart, Deutschland - Lionstep AG

Lionstep AG

Geprüftes Unternehmen

Stuttgart, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

On behalf of
medmix Group AG, we are searching for their next
Employee Quality Assurance Design Control.

Job Summary
Are you ready to take your career in quality assurance and design control to the next level? Then keep on reading

Haselmeier, a part of medmix, is looking for you as
Employee Quality Assurance Design Control (a) at the location in Stuttgart, Germany.

In your position you will collaborate closely with the development team, ensuring regulatory and normative compliance throughout the product life cycle.

Your expertise will be instrumental in supporting engineering and QA functions at manufacturing sites, developing essential documentation and ensuring quality standards are met.

Look forward to a challenging and rewarding position where you can contribute to driving quality and regulatory compliance excellence. Enjoy a supportive work environment and opportunities for professional growth.

We have sparked your interest? Then arrange an initial interview with us now
- #QualityAssuranceExcellence #DesignControl #RegulatoryCompliance #ProfessionalGrowth_

What You Will Be Doing

QA partner of the development team for autoinjectors and drug/device combination and 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 development /DHF documentation and support for the RA function in developing the documentation for regulatory submissions
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

What You Bring To The Job

Degree in technical engineering, ideally in the field of medical devices / biomedical engineering
Several years experience in development / life cycle projects of autoinjectors or similiar 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 handson mentality
Precise and factoriented communication
Travel RequirementsTravel to other locations, 15 % per month, e.g. to Buchen in the Odenwald or to the Czech Republic (Dneszice)

Ge: B