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Quality Assurance Specialist

2 months ago


Suwanee, Georgia, United States Femasys, Inc Full time
About Femasys, Inc.

Femasys, Inc. is a leading biomedical company dedicated to addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products.

Job Summary

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

Key Responsibilities
  • 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
Requirements
  • Bachelor'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
  • Experience with medical device GMP
Physical Requirements
  • Good vision
  • Good manual dexterity
  • Ability to lift over 25 lbs.
Why Femasys, Inc.
  • Opportunity to make a significant impact on women's healthcare through innovative products
  • Collaborative and inclusive work environment
  • Competitive salary and benefits package

Femasys, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.