Quality Assurance Specialist
Summary
A hands-on Quality Assurance Specialist at a women's health medical device company, owning the customer complaint handling system and the equipment maintenance & calibration program while supporting the QMS (FDA 21 CFR Part 820, ISO 13485), audits, CAPA, and quality records on-site in Suwanee, GA.
About Femasys
Femasys is a pioneering biomedical company focused on advancing women's health by developing and commercializing innovative, accessible solutions for reproductive care. Our product portfolio includes breakthrough technologies for permanent contraception, fertility enhancement, and diagnostic procedures — providing meaningful options for both patients and healthcare providers.
Position Summary
We are looking for a Quality Assurance Specialist who thrives in a small, fast-paced environment and wants to play a hands-on role in bringing innovative medical devices from concept to market. This position is responsible for supporting and maintaining the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements, industry standards, and company procedures. This role serves as the primary owner of the Customer Complaint Handling System and the Equipment Maintenance and Calibration Program, ensuring processes are effectively implemented, monitored, and continuously improved. The QA Specialist collaborates cross-functionally with Manufacturing, Engineering, Regulatory Affairs, Customer Service, and Operations to maintain product quality, regulatory compliance, and patient safety.
Core Responsibilities:
- Quality Management System Support
- Support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS).
- Ensure compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and other applicable regulatory requirements.
- Prepare, review, and maintain quality procedures, work instructions, forms, and records.
- Assist with internal and external audits, including preparation, execution, response, and follow-up activities.
- Support CAPA, nonconformance, risk management, and change control activities as assigned.
- Monitor quality metrics and generate reports to support management review activities.
- Customer Complaints
- Serve as system owner for the Customer Complaint Handling process.
- Receive, document, investigate, and process customer complaints in accordance with company procedures and regulatory requirements.
- Perform ERP transactions for complaint returns.
- Perform preliminary complaint assessments and coordinate investigations with cross-functional teams.
- Ensure complaint records are complete, accurate, and maintained in accordance with retention requirements.
- Monitor complaint timelines to ensure timely closure and regulatory compliance.
- Analyze complaint data and trends to identify recurring issues, opportunities for improvement, and potential CAPA inputs.
- Prepare complaint metrics and summaries for Management Review meetings.
- Support regulatory inspections and audits involving complaint handling activities.
- Equipment Maintenance and Calibration System
- Serve as system owner for the Equipment Maintenance and Calibration Program.
- Maintain the inventory list of production, inspection, test, and monitoring equipment.
- Coordinate preventive maintenance and calibration activities with internal personnel and external service providers.
- Verify equipment calibration status and ensure traceability to recognized standards when applicable.
- Review calibration certificates and maintenance records for completeness and compliance.
- Investigate overdue calibrations, maintenance deviations, or equipment-related quality issues.
- Ensure equipment is appropriately identified, labeled, and controlled to prevent unintended use of out-of-calibration equipment.
- Monitor program performance metrics and identify opportunities for process improvement.
- Support equipment qualification and validation activities as required.
- Quality Records and Compliance
- Maintain quality records in accordance with document control requirements.
- Participate in quality investigations and root cause analysis activities.
- Support other Quality Management System activities, as needed.
- Assist with inspection or line clearance activities, as needed.
What We’re Looking For:
- High school diploma or GED required.
- 3 -5 years of experience in Quality in a regulated industry
- Basic understanding of customer complaint handling and equipment and calibration programs.
- Ability to interpret procedures, work instructions, specifications, and technical documentation.
- 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.
- Willingness to contribute to other departments as necessary.
What We Offer
- Comprehensive health benefits (medical, dental, vision)
- 401(k) with match
- Opportunity to make a meaningful impact in women’s reproductive health