BioTalent Cologne, North Rhine-Westphalia, Germany Quality Assurance Manager At BioTalent, we are working with a client to fill their QA Manager position. They are a transformative Device company focused on developing new class 1 + 2 devices for a range of products. Get AI-powered advice on this job and more exclusive features. You will be responsible for their QA/RA set up. What this role offers you To work in a fast-paced environment and the ability to take a huge impact. Be one of the first team members within the quality team. Exposure to high visibility from the senior leadership team. You will be responsible for Quality Operational Activities from CAPA, NCR, Complaints, MDR and further. Support both internal and external auditing in a front office facing role. Lead QMS updates. Support documentation updates including risk management and design history files. Required experience and skills Hands on Quality experience within a device or IVD products in an ISO13485. Worked to lead internal and supplier auditing. Ideal would be a certified lead auditor. Previous track record of updating QMS. Experience within CAPA, Post marketing, NCR, Complaint management. BSc or MSc in a relevant Life Sciences subject. To be part of an innovative thinking, growing company where you can grow and expand your current knowledge, please email me at michael.kakoullis@biotalent.com or call +41 460 85 32 if you think you could be a good match. Seniority level Mid-Senior level Employment type Full-time Job function Quality Assurance and Production Industries Medical Equipment Manufacturing and Manufacturing #J-18808-Ljbffr