Senior Medical Device QA Engineer — ISO 13485, Hybrid

Eko Health; Emeryville (CA); Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

Paid time off

Medical/Dental/Vision insurance

401(k) match

Flexible schedules

Wellness programs

Learning and development stipend

Job summary

A leading digital health company in Emeryville, CA is seeking a Product Quality Assurance Engineer to ensure compliance with industry regulations and internal standards. This hybrid role involves collaborating with product development teams to drive quality initiatives and maintain rigorous quality management processes. Ideal candidates will have over 5 years of experience in a regulated quality assurance environment. Competitive benefits package offered.

Qualifications

• 5+ years of experience in Quality Assurance/systems role within a regulated industry.
• In-depth knowledge of ISO 13485 and 21 CFR 820.
• Demonstrated experience leading compliance with medical device standards.

Responsibilities

• Support new product development ensuring compliance with regulations.
• Act as QA point of contact for validation and risk management activities.
• Maintain product design documents and risk management files.

Skills

Quality systems

Risk management

GxP knowledge

FDA regulations

ISO standards knowledge

Education

Bachelor’s degree in engineering, quality, life sciences, or related field

Job description

A leading digital health company in Emeryville, CA is seeking a Product Quality Assurance Engineer to ensure compliance with industry regulations and internal standards. This hybrid role involves collaborating with product development teams to drive quality initiatives and maintain rigorous quality management processes. Ideal candidates will have over 5 years of experience in a regulated quality assurance environment. Competitive benefits package offered.