Position Summary
We are seeking a highly motivated Quality Engineer & Regulatory Specialist to support the development, validation, and regulatory compliance for advanced cell-processing and cell-therapy instrumentation systems. This role combines quality engineering, device validation, regulatory affairs, supplier quality management, and cross-functional technical leadership to ensure the performance, safety, and compliance of FDA-regulated medical devices used in cell therapy manufacturing applications. The ideal candidate will possess strong analytical and technical problem-solving skills, experience with regulated medical devices, and the ability to evaluate biological and engineering data to support product quality and regulatory objectives.Essential Job Duties
- Involve in the verification and validation (V&V) activities for cell processing and cell sorting systems. Develop test methods, acceptance criteria, and review validation reports.
- Perform incoming inspection and verification of mechanical, optical, and biological components to ensure compliance with engineering and quality requirements.
- Conduct risk assessments in accordance with ISO 14971 to evaluate device safety, performance, and biological impact on cells.
- Prepare and review technical and regulatory documentation supporting FDA submissions, Device Master Files (DMF), and quality records.
- Maintain and improve the Quality Management System (QMS) in compliance with ISO 13485 and FDA 21 CFR Part 820 requirements.
- Support supplier quality management activities, including supplier qualification, technical review, and design transfer coordination with international manufacturers.
- Develop and execute equipment qualification protocols (IQ/OQ/PQ) and maintain audit-ready instrument logbooks. Calibrate and maintain laboratory instruments critical to device testing and quality control operations.
- Review engineering changes and support product quality oversight to ensure device performance and reliability.
- Compile, analyze, and statistically trend complex QC datasets; apply advanced statistical methods to identify process signals and support continuous improvement. Also, prepare rigorous data packages supporting regulatory filings.
- Participate in cross-functional engineering, manufacturing, quality, and regulatory projects to support process improvements and product development initiatives.
Minimum Qualifications
- Bachelor’s degree in biomedical engineering, Bioengineering, Biological Engineering, Biotechnology, Mechanical Engineering, or related engineering/scientific discipline.
- Experience or academic background in medical device quality systems, validation, biological systems, or regulated laboratory environments.
- Knowledge of FDA regulations, ISO 13485, and medical device quality systems.
- Experience with technical documentation, data analysis, and validation activities.
- Strong analytical, organizational, and problem-solving skills.
- Ability to work collaboratively in cross-functional engineering and regulatory environments.
- Excellent written and verbal communication skills.
Salary:
$85,000.00/yearPreferred Qualifications
- Experience with cell therapy, cell processing systems, flow cytometry, microfluidics, or biomedical instrumentation.
- Familiarity with FDA submissions, Device Master Files, or regulatory technical writing.
- Experience supporting supplier quality management or international manufacturing.
Technical Skills
- Statistical analysis and experimental methods
- Risk management and failure analysis
- Validation protocol development and execution
- Technical report writing and documentation control
- Quality systems and CAPA management
- Data trending and process improvement methodologies
Work Environment
- Combination of laboratory, manufacturing, and office environments.
- May require interaction with engineering teams, suppliers, and regulatory agencies.
- Occasional domestic or international supplier communication or audit support may be required.
