Expert Quality Assurance (mfd)
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
At Fresenius Medical Care were dedicated to improving the lives of patients with chronic kidney disease through innovative high-quality products and treatments. Our visionCreating a future worth living. For patients. Worldwide. Every everything we do. With over 125000 people working across 3700 dialysis centers and 39 manufacturing sites worldwide we provide direct patient care through our Care Delivery network develop and supply medical products therapies digital solutions via Care Enablement and accelerate transformation through our FME Reignite strategy. Our values drive us: We Care for our patients each other and our communities. We Connect across teams and borders to deliver excellence together. And we Commit to doing things the right way growing with purpose and leading kidney care with innovation and compassion.
As part of this commitment Systems Quality & Regulatory (SQR)a global function within Care Enablementensures product quality and safety regulatory compliance and market access throughout the entire product lifecycle. The team drives quality across manufacturing and supply chain processes manages post-market surveillance and promotes continuous improvement system harmonization and sustainability. SQR also oversees Q&R data governance and delivers key product-related business services. Join our passionate team and help shape healthcare worldwide!
Goal of function: This function provides key support to the Manufacturing Quality operations at our Ober-Erlenbach site by monitoring implementing executing and coordinating the activities and requirements related to the Production Responsibility over the applicable Disinfectant Contract Manufacturing Organizations (CMOs).
Your Responsibilities:
- Ensure manufactured products at the CMO applicable locations (Non-FME sites) meet all required quality control parameters by executing the final product release process
- Create and/or approve quality documentation as per internal and external requirements (e.g. validation protocols quality agreements quality plans CMO files)
- Ownership and execution of NCCAPA records related to applicable CMO location deficiencies
- Execute product complaint investigations related to applicable CMOs
- Design transfer activities linked to change control execution for the related CMO manufacturing processes in support to the Design Ownership team
- Identify and report problems relating to products processes and quality systems
- Audit hosting and execute on the CMO related processes as required
- Support in quality operations processes at Ober-Erlenbach site as required (complaint investigations batch release supplier management document management change control)
- Monitor and analyze KPIs and creating reports
- Support planification execution and communication during internal and external audit processes applicable for Ober-Erlenbach site
Your Profile:
- Graduate University degree (BA) in mathematics science engineering or related technical discipline
- Mininum of 3 years practical experience in Quality Management System for Non Active Medical Devices. (Audits Document Management NCCAPA Validation Supplier Management Change Control Risk Management)
- Minimum 2 3 years experience in working in the MedTech or the Pharma industry
- Proficient in German and highly fluent in English both written and spoken
- Highly responsible with strong communication negotiation skills and a proactive mindset; effective in independent roles and international cross-cultural environments.
- Good understanding and sound knowledge of ISO 13485 ISO 90001 ISO 23500
- Electronical management system (SAP Trackwise LMS etc.)
Our Offer for you:
There is a lot you can discover at Fresenius Medical Care regardless in which field you are an expert and how much experience you have - all dedicated to your professional journey.
- Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world
- Individual opportunities for self-determined career planning and professional development
- A corporate culture in which there is enough room for innovative thinking - to find the best solution together not the quickest one
- A large number of committed people with a wide range of skills talents and experience
- The benefits of a successful global corporation with the collegial culture of a medium-sized company
Key Skills
- Test Cases
- SQL
- Quality Assurance
- Agile
- TFS
- Jira
- Software Testing
- Test Automation
- Cucumber
- QA/QC
- SDLC
- Selenium
About Company
Fresenius Medical Care provides healthcare professionals with products and solutions for patients renal failure and CKD. Learn more about our product line.
