Quality Assurance Technician
4 weeks ago
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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