Quality Engineering Associate III - CQV

Capricor Therapeutics, a publicly traded (NASDAQ : CAPR) biotechnology leader, is driven by a mission to develop groundbreaking biologicsfocusing on cell and exosome-based therapiesto make a meaningful impact on patients lives, particularly for severe conditions like Duchenne muscular dystrophy with our lead therapy, deramiocel (CAP-1002). Our innovative work extends to our StealthX exosome platform, harnessing cutting?edge science to address unmet medical needs through precision?engineered solutions. At the heart of everything we do is a deep commitment to patient?centered innovation, fueled by strong academic partnerships and a passion for advancing healthcare.

We are seeking a Quality Engineer III to lead equipment and facilities CQV (Commissioning, Qualification, and Validation) activities and drive continuous improvement initiatives for Capricors GMP facility in San Diego. This senior?level role ensures compliance with internal procedures and regulatory guidelines while providing technical leadership in risk management, vendor qualification, and audit readiness. You will serve as a key resource for greenfield and brownfield facility projects, guiding quality engineering strategies that support operational excellence and regulatory compliance.

Responsibilities

• Lead CQV activities for equipment and facilities in alignment with Capricor procedures and regulatory standards.
• Author and approve validation protocols, reports, and related documentation.
• Collaborate with Manufacturing, Facilities, Safety, and Quality teams to maintain compliance and operational efficiency.
• Drive process improvements and implement best practices across quality systems.
• Review calibration, preventive maintenance, and service reports for GMP equipment and facilities.
• Provide technical assessments and evaluations within the change control process.
• Conduct risk assessments using tools such as FMEA, Risk Matrix, and Decision Trees.
• Oversee vendor qualification and compliance audits; prepare technical and investigation reports as needed.
• Support internal and external audits, including regulatory inspections.
• Track and report key quality metrics to inform continuous improvement initiatives.
• Lead quality?related projects and mentor junior team members.
• Perform additional duties as required.

Requirements

Work Environment and Physical Demands

$92,500 - $114,000 a year

Why Capricor?

Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient?centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission?driven group thats transforming lives with every breakthrough.

Come Work With Us!

At Capricor, youll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting?edge therapies.

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