Quality Engineering Manager
About The Position
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.
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.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
101-250 employees
