Manufacturing Quality Engineer Job Suwanee area,Georgia USA,Quality Assurance

Femasys is a dedicated team of experts united by a shared passion to advance technologies that address genuine gaps in women’s health.

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Position:Manufacturing Quality Engineer Location: Suwanee, GA
Job :156 # of Openings:1 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 Manufacturing Quality Engineer 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 production operations to ensure medical devices are manufactured in compliance with established quality requirements, regulatory standards, and company procedures. This role partners closely with Manufacturing, Operations, Supply Chain, and Engineering teams to improve product quality, investigate quality issues, implement corrective actions, and drive continuous improvement initiatives.

The Manufacturing Quality Engineer serves as the primary quality representative for manufacturing processes, nonconformance investigations, process validation, inspection activities, and production quality metrics.
Core Responsibilities:

Manufacturing Quality Support
- Provide day-to-day quality engineering support to manufacturing operations.
- Ensure products are manufactured in accordance with approved specificaitons and quality requirements.
- Assist in review and disposition of nonconforming materials and products.
- Support production issue resolution and quality event investigations.
- Analyze scrap, rework, and defect trends to idetnify improvement opportunities.
Nonconformance, Complaint and CAPA Support
- Lead investigations for nonconformances, deviations, and quality issues.
- Conduct root cause analysis across Nonconformances, complaints and CAPAs.
- Initiate and support Corrective and Preventive Actions.
- Verify effectiveness of implemented corrective actions.
Process Validation and Manufacturing Controls
- Assist in developing and executing validation protocols and reports.
- Support equipment qualification and manufacturing process validation activities.
- Monitor process capability and recommend improvements.
- Ensure validated state is maintained through change control activities.
Inspection and Quality Control
- Develop inspection methods, sampling plans and acceptance criteria.
- Review incoming, in-process, and final inspection data for analysis.
- Support quality technicians
- Evaluate measurement methods and inspection equipment.
- Assist with Test Method Validation activities.
Supplier Quality Support
- Investigate supplier-related quality issues.
- Support supplier corrective actions and containment activities.
- Support supplier qualification and monitoring activities.
- Assist with supplier audits, as needed.
Documentation and Compliance
- Review and approve manufacturing-related quality documentation.
- Support Change Control (Management of Change) activities
- Ensure Device History Records and quality records meet requirements.
- Support compliance with applicable standards and regulations.
Audit and Inspection Support
- Conduct internal audits for evaluation of internal compliance with the QSR, ISO standards and other applicable regulations.
- Participate in FDA, Notified Body and customer audits.
- Lead investigation and corrective actions resulting from audit observiations, when needed.
Continuous Improvement – Identify and drive quality improvement projects to improve…