Senior QA Engineer - Medical Devices (Hybrid)

Cerus; Concord (NH); Hybrid; USD 121,000 - 148,000; Full time

Benefits offered by this job

Competitive benefits package

RSUs

401(k) matching

Job summary

Cerus in Concord, California is seeking a quality assurance and regulatory professional to assure compliance for Class III medical devices and blood component processes, focusing on regulatory standards and robust quality systems. You will support design, risk management, CAPA, supplier quality, device software, and cybersecurity documentation; travel up to 10%.

This role plays a key part in ensuring safe, compliant products across development and production teams.

Qualifications

• Bachelor’s degree or equivalent in engineering or scientific discipline.
• 5 years of quality assurance and quality systems experience supporting manufacturing.
• Familiarity with software testing methodologies and defect management.
• Ability to support cybersecurity documentation and software lifecycle requirements.
• Experience creating and executing test cases, including traceability to requirements.
• Quality certification desired (Six Sigma, CQA, CRE).

Responsibilities

• Participate in cross-functional teams to support new and sustaining product development, quality improvement, quality plans, risk management, and cost savings projects.
• Provide guidance on verification and validation plans, SDLC software testing, IEC 62304 compliance, cybersecurity documentation, change control, sampling methods, and acceptance criteria.
• Perform risk analysis of production, process, and quality data to identify trends and drive quality improvements.
• Perform product release and product quality reviews.
• Maintain quality tracking tools and dashboards to improve visibility and closure timelines.
• Create and review regulated documents for Cerus products such as SOPs, specs, and validation reports.
• Conduct internal and supplier audits to support Cerus quality management.

Skills

Quality Assurance

Regulatory compliance

IEC 62304

Software lifecycle

CAPA

Audits

Education

Bachelor's degree in engineering or scientific discipline

Tools

Smartsheet

Veeva

FMEA/HA

DOE

Job description

Cerus in Concord, California is seeking a quality assurance and regulatory professional to assure compliance for Class III medical devices and blood component processes, focusing on regulatory standards and robust quality systems. You will support design, risk management, CAPA, supplier quality, device software, and cybersecurity documentation; travel up to 10%.

This role plays a key part in ensuring safe, compliant products across development and production teams.