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Quality Assurance Specialist

2 months ago

Alpharetta, United States Remington Medical, Inc. Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at Remington Medical, Inc. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our medical devices and adhering to regulatory requirements.

Key Responsibilities
  • Verify product documentation to ensure compliance with regulatory requirements
  • Conduct accurate product and raw material inspections and testing
  • Perform environmental monitoring of cleanrooms
  • Assist with endotoxin testing and in-house equipment calibrations
  • Resolve quality issues in a timely manner
  • Ensure compliance with Quality System SOPs, GMPs, GDPs, ISO, and FDA requirements
Requirements
  • High school diploma or equivalent required
  • Associates degree in a technical field or equivalent work experience preferred
  • 3+ years of experience in quality assurance or a related field
  • Working knowledge of GMPs, GDPs, FDA QSRs, and ISO 13485 requirements
  • Ability to conduct sterilization and device history record audits
  • Intermediate or above level of proficiency with MS Office applications
  • Ability to utilize basic math skills and interpret instructions
  • Ability to use inspection and test equipment with accuracy and repeatability
  • Excellent written and verbal communication skills
Working Conditions

This position requires the ability to work in a fast-paced environment and adapt to changing priorities. The ideal candidate will have excellent communication and problem-solving skills, as well as the ability to work independently and as part of a team.

Remington Medical, Inc. is an equal opportunity employer and welcomes applications from diverse candidates.