Senior Supplier Quality Engineer
South San Francisco, CA /
Quality – Quality /
We are seeking an innovative and highly motivated Senior Supplier Quality Engineer who will be part of Cellares’ Quality group and contribute significantly to the development of our advanced cell therapy manufacturing platform.
The primary focus of this position is to actively lead all aspects of Supplier Quality Engineering activities in an FDA-regulated environment and ensure compliance with cGMP and ISO 13485 requirements.
The Senior Supplier Quality Engineer will work with cross-functional groups to qualify suppliers and monitor their performance as well as collaborate with suppliers to continuously improve performance of key components (reduce scrap, improve process stability, and performance) by implementing process controls and developing quality assurance plans. Tracks data, identifies improvement projects and manages cross-functional implementations to improve supplier performance. This position requires experience working in an FDA regulated industry.
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.
- Work closely with R&D and manufacturing engineering groups to select, review, qualify and approve suppliers.
- Conduct supplier risk assessments and quality audits (GMP, ISO 9001 and ISO 13485) on a regular basis to ensure vendors and their supplies remain in compliance with Cellares standards.
- Promotes the use of Continuous Improvement techniques at suppliers to aid in reduced variability and achieve process control.
- Initiate and follow-up SCAR to ensure complete and effective Root Cause Analysis and CAPA implementation.
- Develop, evaluate, and maintain Supplier Change Assessments, work with internal stakeholders, and perform follow-up as needed with changes to suppliers.
- Lead supplier performance improvement projects in an effort to increase the supplier capability of consistency.
- Work to resolve supplier technical issues in a timely manner to ensure the continuity of supply.
- Maintain a supplier database and include performance evaluations and quality control audits in the database.
- Develop positive relationships and effective lines of communication with suppliers.
- Lead and participate all New Product Qualification processes, conduct qualification audits and close out audit reports in accordance Cellares goals.
- Provide technical guidance to Quality staff assigned to work on common projects.
- Creating quality documentation, protocols, reports, specifications, templates and developing of procedures to ensure a systemic process for design and development, ensuring compliance with regulatory requirements throughout the development and the product life cycle
- 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)
- Working closely with external partners e.g. suppliers, customers, etc, developing strategies and plans for qualifying new suppliers, implementing and overseeing supplier qualification and monitoring programs
- 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, ICH Q9 , 21CFR820, 21 CFR Parts 210,211and part 11 requirements
- Bachelor's level degree or higher in Engineering required.
- 5+ years working experience specifically as a Supplier Quality Engineer.
- Knowledge of GMP, ISO 13485 and ISO 9001.
- Experience working in an FDA-regulated industry
- 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, ISO 14971, and ISO 13485.
- Experience in supporting manufacturing of medical devices desired
- Must possess excellent organizational, clear verbal, and written communication skills
- Must be a critical thinker and active listener with good time management skills in order to work with Suppliers and Project Management teams to define deliverables
- Self-starter with the ability to quickly learn about new processes with very little information provided
- Strong organizational skills
- Advanced knowledge of quality related tools, including, but not limited to (SPC, FMEA, MSA, DOE, and Quality Systems)
- Excellent analytical and communication skills (written and oral)
- 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
- Willingness to travel up to 10% of the time.
Annual Salary Range: $90,000 - $210,000
Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.
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.