Lead Quality Engineer, Medical Devices (QSR/ISO)

Pulse Staffing Limited; Hayward (CA); On-site; USD 120,000 - 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 to ensure FDA and international standards compliance.

You will also manage traceability, biocompatibility, sterilization validation, CAPA, and regulatory submissions while collaborating across departments to support audits, corrective actions,

Qualifications

• Lead QSR/ISO 13485 quality systems across departments.
• Guide design controls and risk management processes.
• Manage validation activities for medical devices.
• Coordinate regulatory submissions and audits.

Responsibilities

• Oversee traceability and CAPA programs.
• Coordinate sterilization validation and biocompatibility activities.
• Collaborate with R&D, manufacturing, and regulatory teams.
• Support regulatory submissions and audits for product launches.

Skills

Quality systems

Design controls

Risk management

Validation

Regulatory submissions

CAPA

Audits support

Cross-functional collaboration

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.