Clinical Quality Manager (Class 3 Med Device)
davis companiesDenver, CO
Clinical Quality Manager (Class 3 Med Device)
davis companiesDenver, COManager L7
Electromedical and Electrotherapeutic Apparatus ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies Manufacturing
APPLY NOWClinical Quality Manager - Fully Remote Direct HireHelp Shape the Future of Implantable Medical Devices We'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 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
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Level
Manager L7
Location
Denver, CO
Occupation
Quality Control Systems Managers
Industry
Electromedical and Electrotherapeutic Apparatus Manufacturing
Posted
9 days ago