Senior Quality Engineer - Medical Devices (Hybrid, LA)

United Pharma; California; Hybrid; USD 110,000 - 170,000; Full time

Job summary

United Pharma in Los Angeles County, CA seeks a Senior Quality Engineer to design, implement, and maintain quality systems supporting the development, manufacturing, and testing of medical devices. The role is hybrid, with collaboration across engineering, regulatory, and clinical teams to ensure compliance and robust product quality throughout the lifecycle.

You will lead risk assessments, root-cause analyses, and CAPA programs, review development deliverables, prepare quality documentation,

Qualifications

• Bachelor’s degree in engineering, science, or a related technical field; advanced degree is a plus.
• Minimum five years in Medical Device Industry or similar regulated industry.
• Minimum seven years of experience in an engineering discipline (R&D, QA, OPS).
• Experience with medical device quality systems (ISO 13485, FDA 21 CFR 820) and risk management (ISO 14971).
• Strong analytical, problem-solving, and documentation skills, with cross-functional collaboration.
• Experience leading audits, managing CAPA programs, and using statistical tools for quality improvement is advantageous.

Responsibilities

• Design, implement, and maintain quality systems and processes.
• Define and execute quality plans, perform risk assessments, lead root cause analyses.
• Review development deliverables (requirements, DV, TM, RM) and drive CAPA actions.
• Collaborate with engineering, manufacturing, regulatory, and clinical teams to ensure compliance.
• Prepare quality documentation and support audits.
• Mentor team members on quality best practices.

Skills

Quality Engineering

Quality Management

QA/QC

Risk Management

Root Cause Analysis

Statistical Tools

Documentation

Cross-functional Teamwork

Analytical Thinking

Audits

Education

Bachelor’s Degree in Engineering

Advanced Degree preferred

Tools

CAPA Programs

FMEA

Statistical Software

Job description

United Pharma in Los Angeles County, CA seeks a Senior Quality Engineer to design, implement, and maintain quality systems supporting the development, manufacturing, and testing of medical devices. The role is hybrid, with collaboration across engineering, regulatory, and clinical teams to ensure compliance and robust product quality throughout the lifecycle.

You will lead risk assessments, root-cause analyses, and CAPA programs, review development deliverables, prepare quality documentation,