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Quality Assurance Technician
2 months 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.
Employment Type
- Full-time
- On site
Why Join 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.
If you are a passionate Quality Assurance Professional with a hands-on approach and a desire to make a difference in women’s healthcare, we would love to hear from you. Apply today to join our dedicated team at Femasys Inc.
Equal Employment Opportunity Policy
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.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
