Quality Assurance Technician

4 weeks ago


Suwanee, United States Femasys Inc. Full time

About Us

Femasys, Inc. is a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products. We are looking for a Quality Assurance Technician to join our team. 


Position Summary

This position is responsible for operating and maintaining Quality Assurance/ Control Systems, performing receiving, WIP, and final inspections among other support functions.


Specific Job Functions

  • Responsible for quality control daily operations to include final product testing and release, receiving and in-process testing
  • Performing environmental monitoring activities
  • Create or revise department procedures, work instructions, and material specifications as needed
  • Conduct internal audits for evaluation of compliance with the QSR and ISO standards
  • Process change orders in eQMS
  • Perform other duties as assigned


Minimum Qualifications, Education & Work Experience

  • B.S. degree required with a minimum of 3 years’ experience in a Quality-related role within a regulated industry (pharma, med device, IVD).
  • Prefer degree in Biology, Chemistry, or other Science-related field
  • Good working knowledge of FDA Quality System Regulation 21 CFR Part 820, and ISO 13485
  • Good organizational skills
  • Attention to detail a must
  • Excellent verbal and written communication skills
  • Ability to interact and communicate in a positive and professional with senior management and technical staff at all levels
  • Proficiency in MS Word, MS Excel, and general database related software
  • Manual dexterity is a must in order to effectively inspect and test components and finished goods
  • Willingness to contribute to other departments as necessary


Preferred Qualifications, Education & Work Experience

  • Experience with medical device GMP


Physical Requirements

  • Good vision
  • Good manual dexterity
  • Ability to lift over 25 lbs.


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