Quality Assurance Manager

Job Title: Quality Assurance Manager Employment Type: Full time;Salary $50-70k (Based on experience)Location: Memsel Inc. lab / office located at University North Texas Health, Fort Worth, TX Position Summary The Quality Assurance Manager is responsible for leading, maintaining, and continually improving the organization's Quality Management System (QMS) in accordance with ISO 13485, 21 CFR 820, and applicable FDA regulatory requirements. This role ensures that all medical device development, manufacturing, testing, and documentation activities meet required quality and compliance standards. The Quality Assurance Manager serves as the primary point of contact for internal and external audits, regulatory inspections, supplier quality oversight, and cybersecurity compliance related to CMMC Level 2. This position requires strong leadership, cross-functional collaboration, and hands-on experience implementing and maintaining robust QMS processes in a medical device environment.Roles and Responsibilities Maintain and oversee the company's ISO 13485 compliant QMS, ensuring proper documentation, change control, internal audits, and CAPA management.Ensure full compliance with 21 CFR 820 Quality System Regulation for medical device development, testing, manufacturing, and quality controls.Lead internal audit programs, prepare the company for regulatory inspections, and act as the primary liaison during FDA, ISO, and customer audits.Manage nonconformance investigations, root-cause analysis, corrective and preventive actions (CAPA), and effectiveness verification.Support risk management activities in alignment with ISO 14971, including hazard identification, risk evaluation, and risk control documentation.Collaborate with engineering, manufacturing, R&D, and regulatory teams to ensure quality requirements are incorporated into processes, products, and documentation.Develop, review, and update quality procedures, work instructions, and related documentation to ensure regulatory and operational accuracy.Oversee supplier quality activities, including qualification, performance monitoring, and corrective actions.Maintain documentation and ensure compliance to DoD CMMC Level 2 cybersecurity requirements as they pertain to quality data, controlled unclassified information (CUI), and secure QMS operations.Train personnel on QMS processes, quality requirements, and regulatory expectations.Implement continuous-improvement initiatives using data analysis, metrics, and industry best practices.Prepare quality reports, dashboards, and management review inputs.Qualifications Required:Bachelor's degree in engineering, life sciences, quality, or a related field.3+ years of experience in Quality Assurance or QMS management within the medical device, biotech, or related regulated industry.Working knowledge of ISO 13485 and 21 CFR 820 requirements.Experience supporting FDA audits or ISO 13485 certification audits.Strong understanding of document control, CAPA, risk management, and validation requirements.Familiarity with CMMC Level 2 cybersecurity compliance in regulated environments.Excellent communication, documentation, and organizational skills.Preferred:ASQ, CQE, CQA, or related professional certification.Experience with laboratory-based device development or testing.Knowledge of ISO 14971 risk management for medical devices.Experience with electronic QMS tools or digital quality documentation systems.Lean Six Sigma training or experience with continuous-improvement frameworks.Benefits Medical, Dental and Vision Insurance Life Insurance Short-term/Long-term Disability Paid time off; Including vacation and sick leave Company-Observed Holidays Additional Legal Requirements:Must be authorized to work in the United States.The company is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Employment is contingent upon successful completion of a background check and eligibility to work in the U.S.

Created: 2026-05-09