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Senior Quality Assurance Engineer

Employer
X4 Life Sciences
Location
Grand Central, NY
Closing date
Mar 27, 2023
X4 Life Sciences have partnered with a medical equipment manufacturer who act as a product development firm creating future-shifting products where speed-to-market is paramount.

They are looking to add a hands on Senior Quality Engineer to their Brooklyn based office who can oversee all quality functions and report directly to the Quality Director.

Essential skillsets include:

  • Perform quality documentation reviews and updates to ensure compliance and consistency with applicable regulations and ISO 13485:2016 standard
  • Implement a Quality Management System (QMS) compliance with EN/ISO 13485 and 21 CFR 820 requirements
  • Work closely and perform tasks of other teams in the company (R&A, Clinical, R&D,Production, Operations and Supply chain) as assigned
  • Oversee production batch release process at third party manufacturers


Interviews for this role are taking place this week and next, so please apply within if interested.

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