Job DescriptionKey Responsibilities:Serve as the primary expert on Quality Management Systems, including ISO 9001 and other relevant standards.Develop, implement, and maintain QMS policies, procedures, and documentation.Lead internal and external audits; ensure audit readiness and follow-up on corrective actions.Collaborate with cross-functional teams to ensure QMS compliance across departments.In-depth knowledge of ISO 9001 and other quality standards.Familiarity with regulatory requirements (e.g. FDA, ISO 13485, etc., if applicable).Provide training and mentorship on QMS principles, tools, and best practices.Analyze quality data and metrics to identify trends and areas for improvement.Support risk management and root cause analysis for quality-related issues.Stay updated on industry regulations and standards; ensure timely updates to QMS documentation.Participate in quality reviews, CAPA processes, and management review meetings.GXP Regulations21CFR Part11 & Part 21 RegulationsHIPAAISO13485 RegulationsVerification TestingGood Manufacturing Practice RegulationsCSV RegulationsSoftware as a medical device (SaMD)IEC 62304 & 82304 RegulationsPenetration Testing, Security
