Quality Systems Engineer — Regulated Medical Devices

Nudge Real Estate; San Francisco (CA); On-site; USD 80,000 - 110,000; Full time

Job summary

A technology-focused company in San Francisco is seeking a Quality Systems Engineer to ensure product compliance with safety and performance standards. You will collaborate on new product development and lead quality initiatives while managing regulatory requirements. Candidates should have a background in engineering or a related scientific field with at least 2 years of relevant experience. Strong technical writing skills and familiarity with Good Clinical Practice are essential for this role.

Qualifications

• At least 2 years of industry experience in quality systems.
• Familiarity with Good Clinical Practice (GCP).
• Experience conducting risk management activities using FMEA.

Responsibilities

• Ensure product designs meet safety and performance requirements.
• Lead quality discussions in new product development.
• Manage multiple tasks and execute change orders.

Skills

Design controls

Product/process validation

Risk management

Technical writing

High integrity

Education

Degree in engineering or scientific discipline

Job description

A technology-focused company in San Francisco is seeking a Quality Systems Engineer to ensure product compliance with safety and performance standards. You will collaborate on new product development and lead quality initiatives while managing regulatory requirements. Candidates should have a background in engineering or a related scientific field with at least 2 years of relevant experience. Strong technical writing skills and familiarity with Good Clinical Practice are essential for this role.