Employee Quality Assurance Design Control
vor 4 Wochen
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 hands-on mentality
- Precise and fact-oriented communication
- Travel RequirementsTravel to other locations, 15 % per month, e.g. to Buchen in the Odenwald or to the Czech Republic (Dneszice)
- Ge: B2 - Upper Intermediate
- En: B2 - Upper Intermediate
**Nice-to-Haves**
- Previous experience with pens or combination products
**Team**
- Reports to: Thomas Haunsberger
- Colleagues: 6
**Benefits**
- Employee savings plan
- Hybrid or remote work schedule
- Flexible work options
- Sodexo Benefits Pass €50/month
- 30 days of holiday
- Flexitime account
- Fruit basket and beverages (Water, coffee and soft drinks)
- Laptop, (Mobile phone)
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