Lead Quality Engineer, Medical Devices (QSR/ISO)

Pulse Staffing Limited; Hayward (CA); On-site; USD 145,000 - 180,000; Full time

Job summary

Pulse Biosciences in Hayward, CA seeks a Senior Quality Engineer to lead QSR/ISO 13485 quality systems for CellFX medical devices. You will guide design controls, risk management, and validation activities across R&D, manufacturing, and regulatory teams, ensuring compliance with FDA and international standards.

You will manage traceability, biocompatibility, sterilization validation, CAPA, and regulatory submissions, collaborating across departments to support audits and product launches.

Qualifications

• Bachelor’s degree in Engineering or related field.
• 10+ years as a Quality Engineer in Class III/II medical devices; cardiovascular exposure preferred.
• Extensive experience with FDA QSR (21 CFR Part 820 & Part 11) and ISO 13485/MDR.
• Knowledge of ISO 14971, ISO 10993, ISO 11135/11137, ISO 11607.
• Hands-on with catheter-based devices from development to commercialization.
• Strong design controls, risk management, traceability, CAPA, packaging validation.
• Proficient in MS Office; excellent communication; able to work independently and in teams.

Responsibilities

• Provide guidance on design controls and compliance.
• Develop and maintain quality engineering processes.
• Lead risk management planning and analysis.
• Create and manage traceability matrices.
• Oversee biocompatibility and sterilization testing.
• Collaborate across departments and support regulatory audits.
• Assist with regulatory submissions and management reviews.

Skills

FDA QSR 820

ISO 13485

Risk Assessment

Biocompatibility

Sterilization Validation

Design Control

Traceability Matrix

CAPA Management

Statistics

MS Office

Communication

Travel Willingness

Education

Bachelor's degree in Engineering or related field

Tools

Microsoft Office

Job description

Pulse Biosciences in Hayward, CA seeks a Senior Quality Engineer to lead QSR/ISO 13485 quality systems for CellFX medical devices. You will guide design controls, risk management, and validation activities across R&D, manufacturing, and regulatory teams, ensuring compliance with FDA and international standards.

You will manage traceability, biocompatibility, sterilization validation, CAPA, and regulatory submissions, collaborating across departments to support audits and product launches.