Quality Assurance Manager at BioTalent in Danbury, Connecticut

Posted in Other 1 day ago.

Type: full-time





Job Description:

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 products

You will be responsible for establishing quality initiatives to support a new GMP facility

This role will offer 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

You will bring the following
  • 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 auditior
  • Previous track record of updating QMS
  • Experience within CAPA, Post marketing, NCR, Complaint management
  • BSc or MSc in a relevant Life Sciences subject

If 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@biotalent.com or on 857-391-6433 if you think you could be a good match.
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