Quality & Regulatory Engineer (QA/RA)

Employer
X4 Life Sciences
Location
Woburn, MA
Closing date
Sep 30, 2022
An innovative and rapidly growing Medical Device company in Woburn, MA is looking for an experienced Quality & Regulatory Engineer (QA/RA). This role will put you at the forefront of ground-breaking technology. The ideal candidate will be courageous and ready to take on an exciting new challenge with a significant purpose.

Summary: Provides Quality & Regulatory support to ensure that all medical products/processes are in full compliance with customer and applicable global regulatory requirements (i.e. ISO 13485, FDA 21 CFR Part 820, EU MDR 2017/745).

This role will interface directly with suppliers as well as cross-functional partners (i.e. engineering, operations, marketing) to drive quality assurance, continuous improvement, and operational excellence.

Travel:

Up to 10% overnight travel may be expected. Travel may be for the following purposes:
  • Training
  • Supplier selection and qualification
  • Conducting and overseeing validation studies


Basic Requirements:
  • Minimum of 2 years working within a Medical Device quality organization
  • Bachelor's Degree or Higher (Engineering or life science degree preferred), or equivalent experience
  • Knowledge and experience with FDA Quality System Regulations, ISO 13485 Quality System Standard, ISO 14971 Risk Management, and other applicable regulations.
  • Experience with EU Medical Device Regulation 2017/745 a plus.
  • Proficient in the use of the following software: Excel, Word, Powerpoint, Google Drive Suite, Gmail
  • Strong analytical, critical thinking, and interpersonal communication


People with more, less or slightly different experience are still encouraged to apply if you think you have the right skills and experience to thrive in the role!

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