Quality Assurance Manager
BioTalent - Danbury, CT
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At BioTalent, we are working with a client exclusively to fill their QA Manager position. They are a transformative Device company focused on developing new class 1 + 2 devices for a range of productsYou will be responsible for establishing quality initiatives to support a new GMP facility This role will offer youTo work in a fast-paced environment and the ability to take a huge impact.Be one of the first team members within the quality teamExposure to high visibility from the senior leadership team.You will be responsible forQuality Operational Activities from CAPA, NCR, Complaints, MDR and furtherSupport both internal and external auditing in a front office facing roleLead QMS updates Support documentation updates including risk management and design history filesYou will bring the followingHands on Quality experience within a device or IVD products in an ISO13485Worked to lead internal and supplier auditing. Ideal would be a certified lead auditior Previous track record of updating QMSExperience within CAPA, Post marketing, NCR, Complaint managementBSc or MSc in a relevant Life Sciences subjectIf you want to be part of an innovative thinking, growing company where you can grow and expand your current knowledge, GET IN TOUCH - Please email me at michael.kakoullis@ or on 857-391-6433 if you think you could be a good match.
Created: 2025-02-22