Quality Systems Specialist

Job TitleQuality Systems SpecialistReports toRegulatory Affairs ManagerDepartmentRegulatory and Quality AssurancePosition OverviewThe Quality Systems Specialist is responsible for the continuous improvement of Corrective and Preventive Actions (CAPA), internal audits, and Quality Management System (QMS) review processes. This role ensures compliance with regulatory requirements, industry standards, and internal policies to maintain and improve the company's quality management practices.Key ResponsibilitiesCAPA Process ImprovementContinuously improve and maintain the overall CAPA process, facilitating its implementation and leading the CAPA review board.CAPA InvestigationsLead CAPA investigations, coordinating the necessary resources to determine root causes, implement corrective actions, and verify the effectiveness of these actions.CollaborationWork closely with cross-functional teams to support quality initiatives and continuous improvement efforts.QMS ImplementationOversee the effective implementation and maintenance of the Quality Management System across the organization.Regulatory ComplianceEnsure the QMS complies with customer requirements, regulatory standards (e.g., RWMIC), and internal policies.Quality Manual MaintenanceRegularly update and maintain the Quality Manual to ensure its contents remain relevant and accurate.Policy DevelopmentDevelop, implement, and monitor quality policies, procedures, and work instructions to align with organizational needs.Procedural AnalysisAnalyze current and future procedural needs of the company to ensure they are met by the quality systems.Internal AuditsOrganize and manage the internal audit system, ensuring the corrective action reporting system is audited effectively. Conduct and lead internal QMS audits as required.Management ReviewGather data and assist in conducting Management Review meetings to assess the effectiveness of the QMS.Subject Matter Expert (SME)Serve as a mentor and subject matter expert in Quality Management Systems, offering support across the organization.Training DevelopmentDesign and deliver in-house training programs, including QSR (Quality System Regulations) and ISO 13485 standards.Regulatory InterfaceAct as the primary interface with ISO registrars and secondary interface with external regulatory agencies.Third-Party AuditsCoordinate third-party audits to review divisional systems and processes, ensuring compliance with CFR 820 and ISO 13485 standards.Data Monitoring & ReportingMonitor and report on quality data, focusing on CAPA and internal audit processes to ensure continuous improvement.Risk AssessmentEnsure risk assessment activities are executed and maintained according to regulatory standards.RequirementsEducationBachelor's degree in a related field (e.g., Engineering, Quality Assurance, Life Sciences).Experience3+ years of experience in quality systems, CAPA management, or regulatory affairs within a regulated industry, preferably medical devices.CertificationsISO 13485, QMS, or CAPA certification is a plus.SkillsStrong knowledge of regulatory requirements (FDA, ISO 13485, CFR 820).Excellent problem-solving and analytical skills.Experience with internal audits and CAPA investigations.Proficiency in developing and implementing quality management systems and procedures.Strong communication and interpersonal skills.Ability to collaborate with cross-functional teams and lead initiatives.Experience with risk assessment and mitigation strategies.EEOLorenz Engineering provides equal employment opportunity to all qualified employees and applicants for employment without regard to race, color, ancestry, national origin, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other category protected by law.

Created: 2025-01-07