Senior Quality Engineer

Catalyst Life Sciences
NJ, United States
Full-time

Opportunity to join a global medical device company currently going through a transition and investing heavily into the Quality team.

Responsibilities

  • Develop and improve inspection methods to analyze product quality
  • Improve product quality by making recommendations for change
  • Work together with relevant teams and departments to improve products
  • Ensure products adhere to company and industry quality standards
  • Own and execute to the company non-conforming process
  • Document results and findings after inspections are carried out
  • Implement a working system to ensure conformity and accuracy in the production process
  • Own and / or execute to the company CAPA process
  • Develop Process Validation protocols

Qualifications

  • 7 years' quality experience in the Medical Devices space and familiarity with 21CFR820 and ISO : 13485
  • Bachelor's degree in engineering preferred
  • High proficiency in computer technology and systems operations
  • Excellent verbal and written communication skills
  • 30+ days ago
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