QA Specialist: Medical Devices & Compliance Lead

Femasys Inc.; Suwanee (GA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Comprehensive health benefits (medical

401(k) with match

Opportunity to impact women's health

Job summary

Femasys Inc. in Suwanee, GA is seeking a Quality Assurance Specialist to support the Quality Management System and regulatory compliance.

You will serve as the owner of the Customer Complaint Handling process and manage the Equipment Maintenance and Calibration Program to ensure accuracy and traceability. The role collaborates with Manufacturing, Engineering and Regulatory Affairs to maintain product quality and patient safety in a fast-paced environment.

Qualifications

• 3-5 years of experience in Quality in a regulated industry.
• Basic understanding of customer complaint handling and equipment and calibration programs.
• Good knowledge of FDA Quality System Regulation 21 CFR Part 820 and ISO 13485.

Responsibilities

• Support the Quality Management System (QMS) and ensure regulatory compliance.
• Own the Customer Complaint Handling process and investigate complaints.
• Oversee Equipment Maintenance and Calibration program and verify calibration status.

Skills

Attention to detail

Communication skills

Organizational skills

Education

High school diploma or GED

Tools

MS Word

MS Excel

Database software

Job description

Femasys Inc. in Suwanee, GA is seeking a Quality Assurance Specialist to support the Quality Management System and regulatory compliance.

You will serve as the owner of the Customer Complaint Handling process and manage the Equipment Maintenance and Calibration Program to ensure accuracy and traceability. The role collaborates with Manufacturing, Engineering and Regulatory Affairs to maintain product quality and patient safety in a fast-paced environment.