Quality Engineer - Medical Devices, Data & Compliance

ADP, Inc.; San Diego (CA); On-site; USD 80,000 - 130,000; Full time

Job summary

Modular Medical in San Diego, CA is seeking a Quality Engineer to join our Quality team. The role ensures compliance with Quality System Regulations, ISO 13485, and applicable regulations, collaborating across functions to support quality goals.

Responsibilities include data analysis and trending for quality metrics, CAPA coordination, audits support, and delivering timely quality deliverables while maintaining strong cross-functional communication.

Qualifications

• Excellent verbal and written analytical/problem-solving, communication, negotiation, interpersonal and presentation skills.

Responsibilities

• Develop data analysis and trending processes for quality metrics, including establishing alert and action limits
• Manages and drives regular review of quality metrics
• Assists in organizing and coordinating the management review process
• Works closely with program teams to ensure timely and accurate completion of Quality deliverables
• Drives quality, reliability, and compliance with standards and regulations
• Conducts nonconformance and complaint investigations, including proper documentation and timely completion
• Acts as the CAPA coordinator
• Responsible for ensuring proper processes and procedures are followed, driving improvements to maintain compliance and enhance efficiency.
• Support both internal & external audits, including front/back room support and audit responses.
• Complies with FDA regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Exercise good judgment in planning and organizing work; monitors performance and reports status.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Skills

Analytical/problem-solving

Communication skills

Interpersonal skills

Presentation skills

Negotiation skills

MS Office proficiency

Education

BS degree in engineering, data science, technical or scientific discipline

Tools

Statistical analysis software

Job description

Modular Medical in San Diego, CA is seeking a Quality Engineer to join our Quality team. The role ensures compliance with Quality System Regulations, ISO 13485, and applicable regulations, collaborating across functions to support quality goals.

Responsibilities include data analysis and trending for quality metrics, CAPA coordination, audits support, and delivering timely quality deliverables while maintaining strong cross-functional communication.