Clinical Quality Manager (Class 3 Med Device)

The Davis Companies Inc.; United States; Remote; USD 130,000 - 180,000; Full time

Job summary

The Davis Companies Inc. is seeking an experienced Clinical Quality Manager to lead QA activities supporting global clinical development programs.

This fully remote, direct-hire role ensures GCP, FDA, MDR, and ISO compliance while upholding patient safety and data integrity. You will integrate clinical quality processes into the QMS, lead risk-based initiatives, conduct audits of sites, CROs, and vendors, and drive CAPAs and continuous improvement while partnering with cross-functional teams to

Qualifications

• Bachelor's degree in Life Sciences or related field required.
• Advanced degree preferred.
• 5+ years of Clinical Quality Assurance experience.
• Strong GCP background and regulatory inspections experience with ISO, MDR, FDA compliance.

Responsibilities

• Lead quality assurance activities supporting global clinical development programs.
• Integrate Clinical Quality processes into the QMS and manage risk-based initiatives.
• Conduct audits of clinical sites, CROs and vendors; oversee CAPAs and investigations.

Skills

GCP

QA experience

Regulatory inspections

eQMS

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Job description

Clinical Quality Manager - Fully Remote Direct Hire

Help 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

• GCP compliance
• Clinical quality audits
• Vendor qualification and oversight
• CRO performance management
• Quality agreements
• Regulatory inspection readiness

Conduct audits of:

• Clinical sites
• CROs and vendors
• 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 …