Quality Engineering Manager

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 StealthX™ 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.

In this role, you will lead the development and continuous improvement of quality engineering processes to ensure product quality and regulatory compliance. You will manage a team of engineers, drive initiatives to resolve complex quality issues, and collaborate with cross-functional teams to maintain high-quality standards in product development and manufacturing.

Responsibilities:
• Lead and manage the Quality Engineering team, providing direction and mentorship.
• Develop and maintain quality engineering processes for compliance and improvement.
• Drive initiatives to enhance product reliability, performance, and safety using engineering principles.
• Lead root cause analysis and corrective action processes for quality issues.
• Collaborate with R&D, Manufacturing, and Regulatory Affairs teams to meet quality standards.
• Manage product qualification, validation, and verification for regulatory compliance (e.g., FDA, ISO 9001, GMP).
• Oversee design and implementation of quality testing methods and metrics.
• Ensure adherence to risk management and process optimization best practices.
• Review and approve quality documentation (e.g., technical reports, validation protocols).
• Develop and implement training programs on quality engineering practices.
• Monitor and report quality performance metrics to identify improvements.
• Stay current with industry regulations and best practices in quality engineering.

Requirements:
• Education: Bachelor’s degree in Engineering, Quality Assurance, Life Sciences, or related field.
• Experience: 6+ years of experience in quality engineering, with 2+ years in a managerial or team leadership role in a regulated industry (e.g., pharmaceuticals, medical devices).
• Regulatory Knowledge: Knowledge of quality engineering principles and regulatory standards (e.g., FDA, GMP, ISO 13485/9001).
• Leadership: Experience leading cross-functional teams and managing quality projects.
• Technical Expertise: Expertise in quality systems, process validation, and statistical analysis.
• Problem-Solving: Strong skills for driving root cause analysis, corrective actions, and improvements.
• Tools: Proficiency in Microsoft Office Suite (e.g., Word, Excel, PowerPoint) and quality management software.
• Communication: Excellent skills for presenting technical information to management and stakeholders.
• Adaptability: Ability to manage multiple projects in a fast-paced environment.

Work Environment / Physical Demands:
• Primarily office-based with required time in GMP spaces addressing quality engineering and documentation.
• Requires prolonged periods of computer use for data analysis, reporting, and documentation.
• May involve lifting equipment or materials up to 20 pounds.
• Ability to navigate office and GMP environments for inspections and coordination.

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.

Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason.

Notice to Recruiting Agencies
Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.