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Company

Leaman Life Sciences
Address Alpharetta, GA, United States
Employment type FULL_TIME
Salary
Category Medical Equipment Manufacturing
Expires 2023-10-13
Posted at 7 months ago
Job Description

My esteemed Medical Device manufacturing client are seeking highly motivated and detail-oriented Quality Engineer to join their dedicated team. As a Quality Engineer, you will play a critical role in ensuring the safety, reliability, and regulatory compliance of our medical device software products.


Responsibilities:

  • Assist in risk assessments, familiarity with ISO 14971 required
  • Assist in preparation for internal and external audits
  • Support regulatory submissions from a quality standpoint
  • Support continuous improvement efforts
  • Assist in document controls
  • Verification and validation


Qualifications:

  • ASQ Certified Quality Engineer is a plus.
  • Some software quality experience strongly preferred
  • Familiarity with relevant quality standards and regulations, such as ISO 13485, IEC 62304, FDA 21 CFR Part 820
  • Proficiency in software testing methodologies, test automation, and defect tracking tools.
  • Bachelor's degree in a relevant field.
  • Proven experience as a Quality Engineer, ideally in medical device manufacturing
  • Strong analytical and problem-solving skills.