Chief Operating Officer
$180,295–$225,856 year
On-site · Martinez, California, United States
Job Summary
COO with a strong quality background to lead and scale ExThera Medical’s operations in Martinez, CA. Drive day-to-day operations across manufacturing, supply chain, and quality; establish and maintain a robust Quality Management System (QMS) in compliance with FDA, ISO 13485, and global regulatory requirements; partner with executives to define and execute strategy; oversee manufacturing processes, vendor management, and regulatory interactions; build and mentor cross-functional teams; implement KPIs to improve efficiency, quality, and cost-effectiveness; support product development and commercialization with a quality/compliance lens; this role requires on-site presence five days per week.
Required Qualifications
- Bachelor’s degree in Chemical Engineering (preferred) or Chemistry required; advanced degree (MBA, MS, or equivalent) preferred
- 15+ years of leadership experience in medical device, biotech, or life sciences
- Demonstrated success in an operations leadership role (VP Operations, COO, or equivalent)
- Deep expertise in quality systems, regulatory compliance, and FDA/ISO standards
- Experience scaling operations in a growth-stage or emerging company environment
- Strong knowledge of GMP, QSR, ISO 13485, and risk management frameworks
- Proven ability to lead through complexity and drive cross-functional alignment
- Excellent communication and executive leadership skills
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