Medical Device Documentation Specialist

3 weeks ago


Austin, Texas, United States The Fountain Group Full time
About the Company

The Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. We specialize in placing top talent in life sciences, clinical, engineering, IT, and more. Our success is built on a commitment to excellence and a passion for helping people grow their careers.

Job Description

We are seeking a talented QA Specialist to join our team. This individual will be responsible for reviewing and approving quality documents, analyzing data, and collaborating with cross-functional teams to implement process improvements.

Responsibilities
  • Review and approve quality documents, including batch records and laboratory notebooks
  • Analyze data to identify trends and areas for improvement
  • Collaborate with cross-functional teams to implement process improvements
Requirements
  • Bachelor's degree in a STEM field, such as engineering or science
  • At least 3 years of experience in a medical device or pharmaceutical regulated environment, preferably in manufacturing
  • Strong understanding of regulatory requirements, including ISO 13485 and FDA regulations
  • Ability to work independently and as part of a team
Compensation

The estimated salary for this role is $32-35 per hour, depending on experience. Benefits include a competitive compensation package, opportunities for professional growth and development, and a supportive work environment.



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