Clinical Quality Manager (Class 3 Med Device)

Clinical Quality Manager - Fully Remote Direct HireSkills, Experience, Qualifications, If you have the right match for this opportunity, then make sure to apply today.Help Shape the Future of Implantable Medical DevicesWe're seeking an experienced Clinical Quality Manager to lead quality assurance activities supporting global clinical development programs. This is a highly visible role responsible for ensuring compliance with GCP, FDA, MDR, ISO requirements, and maintaining the highest standards of patient safety and data integrity.Key Responsibilities Integrate Clinical Quality processes into the Quality Management System (QMS) Lead risk-based clinical quality initiatives Oversee:GCP complianceClinical quality auditsVendor qualification and oversightCRO performance managementQuality agreementsRegulatory inspection readiness Conduct audits of:Clinical sitesCROs and vendorsTrial Master Files (TMF)Clinical databasesPharmacovigilance systems Lead CAPAs, quality investigations, and continuous improvement initiatives Serve as the Clinical Quality representative across cross-functional clinical teams Develop and deliver GCP training programsQualificationsBachelor's degree in Life Sciences, Biotechnology, or related fieldAdvanced degree preferred5+ years of Clinical Quality Assurance experienceStrong xhyhwjd GCP backgroundExperience supporting regulatory inspectionsExperience with electronic Quality Management Systems (eQMS)Highly Preferred Experience Implantable Medical Devices - Neuromodulation products would be a huge bonus FDA, MDR, and ISO compliance Clinical trial quality oversight Clinical vendor and CRO management Risk-based quality management programs Inspection readiness and regulatory audits