Quality Engineering Associate II

Capricor Therapeutics, a publicly traded (NASDAQ: CAPR) biotechnology leader, is driven by a mission to develop groundbreaking biologics—focusing on cell and exosome-based therapies—to 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 Engineering Associate II to join our growing team. This role will support operations and continuous improvement initiatives for Capricor’s GMP facility. The position ensures compliance with internal procedures and regulatory guidelines while contributing to process optimization and quality excellence. In practice, this means applying quality engineering principles to monitor and improve equipment and facility performance, reviewing maintenance and calibration records, and supporting risk assessments and change control processes. You will also play a key role in vendor qualification, audit readiness, and implementing corrective and preventive actions (CAPA) to maintain a robust quality management system.

• Collaborate with R&D, operations, and other site functions, including Manufacturing, Facilities, Safety, and Quality.
• Identify process improvements and recommend changes.
• Review calibration, preventive maintenance, and service reports for equipment and facilities.
• Provide quality support for technical assessments and evaluations within the change control process.
• Prepare reports and documentation related to equipment, facilities, and maintenance activities.
• Ensure alignment of equipment/facilities and IT system qualifications with Capricor procedures.
• Support regulatory inspections and audits.
• Conduct risk assessments using tools such as FMEA, Risk Matrix, and Decision Trees.
• Assist with vendor qualification and compliance audits; prepare technical and investigation reports as needed.
• Track and report quality metrics to drive continuous improvement.
• Contribute to quality-related projects and initiatives within the R&D organization.
• Perform additional duties as required.

• Bachelor’s degree in a scientific or engineering discipline and 2+ years of experience in a pharmaceutical or FDA-regulated environment.
• Minimum of 2 years in Quality Engineering or validation within a GMP setting (Drug Substance or Drug Product).
• Strong knowledge of quality systems and regulatory requirements (21 CFR Parts 11, 210, 211; ICH Q8–Q10).
• Preferred certifications: ASQ Quality Engineering, Six Sigma Green/Black Belt.
• Familiarity with GMPs, Health Authority regulations, and validation principles.
• Understanding of audit principles and quality assurance practices.
• Proficiency in Microsoft Word, Excel, PowerPoint, and related applications.
• Excellent written and verbal communication skills.
• Ability to work independently and collaborate effectively with technical teams.

• Experience with flow cytometry, functional assays, and DNA/RNA/protein analysis is a plus in broader R&D contexts.

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 that’s transforming lives with every breakthrough.

Come Work With Us!

At Capricor, you’ll 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.