Remote Clinical Quality Lead - Implantable Devices

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

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