Senior QA Engineer, Medical Devices IEC62304/Cybersecurity

Jobtailor; Concord (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

Jobtailor is seeking a Quality Assurance professional to ensure regulatory compliance and maintain QA systems for Class III medical device products in California. You will support product development, audits, and risk management while guiding verification and validation for software heavy components.

The role requires 5 years of QA experience in manufacturing, familiarity with IEC 62304, and exposure to cybersecurity documentation. Travel up to 10% may be required.

Qualifications

• Bachelor’s degree or equivalent in an engineering or scientific discipline.
• 5 years of quality assurance and quality systems experience supporting manufacturing.
• Experience with Class III medical devices with hardware/software and consumables is a plus.
• Familiarity with software testing methodologies and defect management.
• Ability to support cybersecurity documentation and software lifecycle requirements.
• Experience creating and executing test cases with traceability to requirements.
• Quality certifications such as Six Sigma, CQA, or CRE are desirable.
• Knowledge of IEC 62304 software lifecycle requirements and risk management.

Responsibilities

• Assure compliance with regulations and standards for Class III medical device products.
• Develop, implement, and maintain quality assurance systems for manufacturing processes.
• Lead cross-functional teams on new and sustaining product development and cost-savings projects.
• Guide verification and validation plans, IEC 62304 documentation, and software testing.
• Analyze production data to identify trends and reduce defects.
• Perform product release and quality reviews.
• Maintain quality dashboards and CAPA tracking tools.
• Create and review SOPs, specifications, and QA documentation.
• Conduct internal and supplier audits and support CAPA investigations.
• Interact with departments and suppliers on quality matters.

Skills

Quality Assurance

Software Testing

Risk Management

Data Analysis

Document Control

Auditing

FMEA/HA

DOE

Compliance

IEC 62304

Veeva

SmartSheet

Education

Bachelor’s degree in engineering or science

Tools

SmartSheet

Veeva

CAPA Tracking

Quality Tracking Tools

Dashboards

Job description

Jobtailor is seeking a Quality Assurance professional to ensure regulatory compliance and maintain QA systems for Class III medical device products in California. You will support product development, audits, and risk management while guiding verification and validation for software heavy components.

The role requires 5 years of QA experience in manufacturing, familiarity with IEC 62304, and exposure to cybersecurity documentation. Travel up to 10% may be required.