Senior QA Engineer, Medical Devices | Compliance & SDLC

simple staffing; Concord (CA); On-site; USD 121,000 - 148,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

RSUs

Paid time off

Job summary

Cerus Corporation in California is seeking a Quality Assurance Specialist to assure compliance for Class III medical devices and blood components. You will support design controls, risk management, supplier quality, and CAPA across cross-functional teams.

The role involves validating software lifecycle activities (IEC 62304), cybersecurity documentation, and QA oversight of production processes. Travel up to 10% may be required, with a competitive benefits package.

Qualifications

• Bachelor’s degree in engineering or scientific discipline.
• 5 years of quality assurance and quality systems experience supporting manufacturing (Class III medical devices 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 certification desired (Six Sigma, CQA, CRE).
• Experience with KPIs and quality metrics in regulated environments.

Responsibilities

• Participate in cross-functional teams to support new and sustaining product development and quality improvements.
• Provide guidance on verification/validation plans, SDLC software testing, IEC 62304 documentation and compliance activities.
• Perform risk analysis of production, process and quality data to identify trends and improvements.
• Perform product release and product quality reviews.
• Maintain quality tracking tools/dashboards to improve visibility and closure timelines.
• Create/review regulated documents for design and manufacture of Cerus products.
• Conduct internal and supplier audits to support Cerus quality management.
• Support QA internal and supplier audits and CAPA investigations.

Skills

Quality assurance

Regulatory compliance

IEC 62304

Software testing

CAPA management

Risk analysis

Audits

KPIs

FMEA/HA

Veeva

Education

Bachelor’s degree in engineering or science

Tools

Smartsheet

Veeva

DOE

Job description

Cerus Corporation in California is seeking a Quality Assurance Specialist to assure compliance for Class III medical devices and blood components. You will support design controls, risk management, supplier quality, and CAPA across cross-functional teams.

The role involves validating software lifecycle activities (IEC 62304), cybersecurity documentation, and QA oversight of production processes. Travel up to 10% may be required, with a competitive benefits package.