Quality Engineering Associate II

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome‑based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late‑stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary Stealth

X™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life‑changing treatments to patients and families who need them most.

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.

$80,000 - $95,000 a year

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.

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.