Quality Systems Engineer - Regulated MedTech Excellence

Nudge; San Francisco (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading technology company in San Francisco is seeking a Quality Systems Engineer to ensure product designs meet safety and performance standards. The ideal candidate will have at least 2 years of experience, a background in engineering or a scientific discipline, and familiarity with FDA regulations and Good Clinical Practice. This role includes leading discussions in product development, managing tasks, and supporting quality initiatives. The company strives to cultivate a culture of quality across teams.

Qualifications

• At least 2 years of industry experience in Quality Systems.
• Familiarity with Good Clinical Practice (GCP) and human factors.
• Knowledge of FDA QMSR, ISO 13485, and ISO 14971.

Responsibilities

• Ensure new and existing product designs meet safety and performance requirements.
• Lead quality discussions and drive process changes.
• Manage tasks and execute change orders.
• Support corrective and preventive actions (CAPAs).
• Cultivate a culture of quality across teams.

Skills

Design controls

Product/process validation

Risk management

Technical writing

High integrity

Education

Degree in engineering or scientific discipline

Tools

FMEA

Job description

A leading technology company in San Francisco is seeking a Quality Systems Engineer to ensure product designs meet safety and performance standards. The ideal candidate will have at least 2 years of experience, a background in engineering or a scientific discipline, and familiarity with FDA regulations and Good Clinical Practice. This role includes leading discussions in product development, managing tasks, and supporting quality initiatives. The company strives to cultivate a culture of quality across teams.