FDA Quality Assurance Manager
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Job Description
FDA Quality Assurance Manager developing and maintaining the Quality Management System for medical devices. Ensuring regulatory compliance and supporting risk management activities across product lifecycle.
Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS), including SOPs and document control.
- Ensure compliance with 21 CFR Part 820 and applicable standards (e.g., ISO 13485, ISO 14971).
- Establish and manage CAPA (Corrective and Preventive Action) processes.
- Oversee complaint handling and evaluate reportability requirements.
- Ensure design controls and software validation processes are in place and followed.
- Conduct internal audits and prepare for FDA inspections.
- Support risk management activities across the product lifecycle.
- Train cross-functional teams on quality and compliance requirements.
Requirements:
- Bachelor's degree in Computer Science, Life Science, or Quality/Regulatory or equivalent combination of education and experience.
- 3–7 years of experience in medical device quality or a regulated industry.
- Working knowledge of FDA Quality System Regulation (21 CFR Part 820).
- Experience with QMS implementation, CAPA systems, and internal audits.
- Familiarity with software development lifecycle (SDLC) and validation principles.
- Preferred: Experience supporting FDA inspection or ISO audits.
Benefits:
- Comprehensive coverage starts first day of employment and includes Medical, Dental/Orthodontia, and Vision.
- All Team Members are eligible for synthetic ownership in Experity upon one year of employment with real financial rewards when the company is successful!
- Employee Assistance Program includes counseling, legal resolution, financial education, pet adoption assistance, identity theft and fraud resolution, and more.
- Experity is committed to helping team members face the demands of juggling work, family and life-related issues by offering flexible work scheduling.
- Experity offers a generous PTO plan that increases with milestones.
- Experity maintains a learning program foundation for the company that allows Team Members to explore their potential and achieve their career goals.
- We bring our Team Members together to strengthen the team, build relationships, and have fun!
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