Senior QA Engineer, Medical Devices (Hybrid)

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

Benefits offered by this job

Health insurance

401(k) matching

Paid time off

Dental insurance

Vision insurance

Life insurance

Disability insurance

RSUs

Job summary

Cerus is seeking a Quality Assurance professional to ensure compliance for Class III medical devices and blood components. The role focuses on building and maintaining QA systems, supporting SDLC, risk management, supplier quality, and CAPA processes in a regulated environment.

You will contribute to design controls, testing methods, and regulatory documentation while collaborating with multiple departments and suppliers to ensure timely product quality and compliance.

Qualifications

• Bachelor’s degree in engineering or scientific discipline required.
• 5 years of quality assurance experience in manufacturing, preferably Class III devices.
• Familiar with software testing methodologies and defect management.
• Ability to support cybersecurity documentation and software lifecycle requirements.
• Experience with traceability to requirements and verification/validation.
• ISO/IEC 62304 knowledge and SARs related to medical devices is a plus.

Responsibilities

• Participate in cross-functional teams to support product development and quality plans.
• Guide verification, validation plans and SDLC documentation including IEC 62304.
• Perform risk analysis to identify trends and improvements in manufacturing quality.
• Conduct product release and quality reviews.
• Maintain quality tracking tools and dashboards (e.g., Smartsheet, CAPA).
• Support audits of design, manufacturing and supplier processes.
• Assist CAPA investigations and assess effectiveness.
• Interact with departments and suppliers on quality matters.
• Travel domestically and internationally ~10% as needed.

Skills

Quality assurance

Regulatory compliance

IEC 62304

Software lifecycle

CAPA

Cybersecurity documentation

Process improvement

Cross-functional collaboration

Education

Bachelor’s degree in engineering or science

Tools

Smartsheet

Veeva

FMEA

DOE

Six Sigma

Job description

Cerus is seeking a Quality Assurance professional to ensure compliance for Class III medical devices and blood components. The role focuses on building and maintaining QA systems, supporting SDLC, risk management, supplier quality, and CAPA processes in a regulated environment.

You will contribute to design controls, testing methods, and regulatory documentation while collaborating with multiple departments and suppliers to ensure timely product quality and compliance.