About Femasys Inc.

Femasys Inc. is a leading biomedical company dedicated to advancing women’s healthcare through innovative medical solutions. Our mission is to provide safe, effective, and accessible products that improve the lives of women worldwide.

Position Summary

Responsible for applying quality assurance principles and techniques in the planning, development, and implementation of quality system processes and procedures to support the various functions of the organization, including R&D and manufacturing.

Specific Job Functions

• Develop, implement, and maintain effective internal quality policies and procedures consistent with company objectives, global customer needs, and global compliance requirements (including FDA QSR/ cGMPs, ISO 13485 requirements, and CE marking guidelines).
• Manage company-wide quality system procedures for executing how the company handles process validation, process control and enhancements, quality metric reporting, supplier qualification, design assurance programs, complaint handling and CAPA programs.
• Responsible for quality control daily operations to include: final product testing and release, receiving and in-process testing, stability testing, QC inspections and audits, and QC documentation.
• Manage material control program to include: QC materials management including labeling and storage, QC materials inventory and use and materials lot control.
• Develop and implement training programs for new and current employees, as applicable, on FDA QSR/ cGMP's, ISO 13485 requirements, and CE marking guidelines.
• Additionally, support engineering in the development, testing, verification, validation and commercialization of new products, or changes to existing products to assure products conform to government and Company standards and satisfies all applicable regulations.
• Support engineering in the qualification and validation of equipment and processes.
• Interface with the FDA, ISO, CE, and other international regulatory agents or surveillance auditors. Respond to regulatory and/or third party audit observations.
• Develop and implement instructions/methods for inspecting, testing and evaluating product conformance to specification.
• Process non-conforming material reports including MRB dispositioning. Work with suppliers to correct problems.
• Maintain the corrective/preventive action program, inclusive of tracking status of open actions, receiving and reviewing responses, working with departments for timely completion and periodic reports and metrics.
• Support manufacturing in the investigation of manufacturing problems and product complaints to determine the root cause and recommend appropriate corrective and preventive action to avoid recurrence. Lead and perform component/ product testing.
• Participate in the development of information databases to support quality system infrastructure.
• Evaluate quality data, prepare periodic reports to monitor trends, and report to management to ensure the Company’s continuous improvement efforts are on track.
• Review and approve reports and other documentation prepared by QA and QC for regulatory submissions/inspections.
• Perform risk analysis to identify appropriate protective measures to mitigate risk associated with identified hazards.
• Interface with external contract test laboratories.
• Perform other duties as assigned.

Minimum Qualifications, Education & Work Experience

• B.S. required with 6-8 years experience in Quality Assurance, Quality Engineering or related functions in a medical device or FDA regulated company. Prefer degree in Engineering, Science or related field. ASQ, CQM (Certified Quality Manager) or CQE (Certified Quality Engineer) is highly desirable.
• Strong knowledge of FDA Quality System Regulation 21 CFR Part 820 (cGMP/ QSR) and related parts, 21 CFR Part 58 (GLPs), ISO 13485, 2017/745 (EU Medical Devices Regulation) and MEDDEV 2.12 (Medical Device Vigilance Guideline).
• 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.
• Understanding of statistics required - Cp, Cpk, AQL, etc.
• Excellent computer skills and proficiency with MS Word, Excel, Access and the Internet.

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.