Clinical Quality Manager (Class 3 Med Device)

Key Responsibilities: ✅ Integrate Clinical Quality processes into the Quality Management System (QMS)✅ Lead risk-based clinical quality initiatives✅ Oversee: GCP compliance Clinical quality audits Vendor qualification and oversightCRO performance management Quality agreements Regulatory inspection readiness✅ Conduct audits of: Clinical sitesCROs and vendors Trial Master Files (TMF)Clinical databases Pharmacovigilance 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 programs

Qualifications: Bachelor's degree in Life Sciences, Biotechnology, or related field Advanced degree preferred 5+ years of Clinical Quality Assurance experience Strong GCP background Experience supporting regulatory inspections Experience 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