Manufacturing Quality Engineer

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 product qualtiy and the quality management system.
• Perform other duties as assigned by quality management.

What We're Looking For:

• Bachelor's degree required with a minimum of 5 years experience in Quality Assurance, Quality Engineering or related functions in a medical device or other FDA regulated business.
• Strong working knowledge of FDA Quality System Regulation 21 CFR Part 820, and ISO 13485.
• Project management experience within a design control structured environment.
• Good organizational, attention to detail and follow-through skills.
• Excellent verbal and written communication skills.
• Demonstrated presentation, facilitation skills and the ability to interact and communicate with senior management and technical staff at all levels.
• Strong knowledge of statistical techniques used in process validation, sample size determination, and trend analysis/ process monitoring.
• Basic computer skills - word processing, spreadsheet, windows required. MS Office preferred.
• Must be willing to travel to suppliers in the U.S.
• 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:

• Prefer degree in Engineering, Science or related field.
• ASQ CQE (Certified Quality Engineer) is highly desirable.
• Class III Medical Device experience.

What We Offer

• Comprehensive health benefits (medical, dental, vision)
• 401(k) with match
• Opportunity to make a meaningful impact in women's reproductive health