Position Summary

We are seeking an innovative and highly motivated Senior Quality Engineer who will be part of Cellares’ Quality group and contribute significantly to the development of our advanced cell therapy manufacturing platform by representing Quality in the design of Single Use Systems for the Cell Shuttle.

The primary focus of this position is to actively lead all aspects of Quality Engineering activities in an FDA-regulated environment and ensure compliance with 21 CFR 210, 211 cGMP and ISO 13485 requirements. 

This is a multidisciplinary role and this individual will interface across many parts of the company (with scientists, researchers, and engineers) and will lead and drive Quality throughout the product life cycle from product development and production builds to market release. 

Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

Responsibility

• Working closely with the design team, providing quality direction and guidance to the development and the design control processes, defining the quality assurance expectations for risk management and design planning strategies and ensuring that each stage of the design and development is adequately documented, recorded and maintained
• Creating quality documentation, protocols, reports, specifications, templates and developing procedures to ensure a systemic process for design and development, ensuring compliance with regulatory requirements throughout the development and the product life cycle
• Performing independent reviews of the product development life cycle deliverables, from the requirements gathering phase to the retirement phase
• Working collaboratively with cross functional teams to define a process and a set of documentation to support and verify the progress of the design and development activities and for managing and controlling the design and development and transferring it to manufacturing
• Ensuring that all design changes are adequately reviewed, evaluated, approved and documented
• Review and approve documentation associated with planning, intended use, user requirements, hazard analysis, risk assessments, functional and design specifications, design reviews, test protocols, requirements trace matrix, Master Validation Plan, V&V packages along with support documentation for equipment and systems
• Collaborating with cross functional teams, including external parties to establish verification and validation plans for test methods, equipment, processes and products using appropriate techniques and identification of risks through execution of FMEA and Risk Analysis
• Maintaining design and development history files (DHF)
• Understanding the single use systems design to facilitate participation in technical discussions and risk-based decision making
• Performing assessments on supplier capability to deliver quality products for single use systems to market and defining the associated technical tests
• Driving root cause analysis investigations and CAPAs and actively participate in continuous improvement activities with cross-functional teams
• Conducting quality audits
• Mentoring and training junior level engineers 
• Participating in regulatory inspections
• Established and promotes an environment that supports the Quality Policy, Data Integrity and Quality System
• Deep understanding of ISO 13485, ISO 14971, ISO 10993 ICH Q9 , 21CFR820, USP, 21 CFR Parts 210,211and part 11, EU Annex 1 requirements

• Bachelor's level degree or higher in Science, Engineering, or Quality Engineering
• 5-7 years of related work experience in Quality Engineering or System Engineering
• Experience working in an FDA-regulated industry
• Knowledge of Design Assurance, preferably with automated manufacturing and computerized lab systems
• Experience working with complex single use systems
• Experience and Advanced knowledge of Sterility Assurance in impacting Product Quality
• Understanding of data integrity requirements and how to perform assessments
• Practical knowledge of 21 CFR Part 11 (electron records/electronic signature), 21 CFR Parts 210, 211, GAMP 5, 21 CFR Part 820 and ISO 14971 ISO 13485, ISO 10993
• Experience in supporting manufacturing of medical devices desired
• Must possess excellent organizational, clear verbal, and written communication skills
• High level of attention to detail and compliance and ability to effectively support multiple high priority deliverables at once
• Hands on approach, self-motivated with a passion for solving problems
• Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset

This is Cellares

Cellares is creating the future of cell therapy manufacturing. The company is developing an innovative cell therapy manufacturing solution that is robust, cost-effective and scalable so that cell therapies are more affordable and widely available to patients in need. Our multidisciplinary team comes together from diverse backgrounds with a shared passion for accelerating access to life-saving cell therapies. We value integrity, curiosity, the courage to grow and embrace change. At Cellares, you will collaborate with a world class team of engineers, scientists, and business leaders who are as excited about improving the world as you are.

Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.