Senior Quality Engineer, Medical Devices & Compliance

Pulse Biosciences, Inc.; Hayward (CA); On-site; USD 145,000 - 180,000; Full time

Job summary

Pulse Biosciences in Hayward, CA is seeking a Principal Quality Engineer to implement and maintain QSR (21 CFR 820) and ISO 13485 quality systems for CellFX System, surgical disposables, and reusable medical devices. You will lead risk management, traceability, biocompatibility, and sterilization validation efforts across R&D, manufacturing, regulation, and clinical programs.

The role requires 10+ years in medical device QA, extensive FDA QSR/ISO knowledge, and the ability to drive CAPA and

Qualifications

• Bachelor's degree in Engineering or related field required.
• 10+ years in a QA engineering role within a Class III/II medical device environment.
• Experience with FDA QSR and ISO 13485/MDR; ISO 14971 risk management.
• Expertise in design controls, traceability, biocompatibility, and sterilization validation.

Responsibilities

• Provide guidance to product development and manufacturing on design controls and compliance.
• Lead risk management efforts and develop risk management plans and reports.
• Establish and maintain traceability matrices and verification activities.
• Oversee biocompatibility, sterilization, packaging validation, and test protocols.
• Support regulatory audits and submissions; drive quality improvements across teams.

Skills

Design Control

Risk Management

Traceability Matrix

Biocompatibility

Sterilization Validation

Packaging Validation

Statistical Analysis

Quality System Compliance

CAPA management

Project Management

Education

Bachelor's degree in Engineering or related field

Tools

Microsoft Office Suite

Job description

Pulse Biosciences in Hayward, CA is seeking a Principal Quality Engineer to implement and maintain QSR (21 CFR 820) and ISO 13485 quality systems for CellFX System, surgical disposables, and reusable medical devices. You will lead risk management, traceability, biocompatibility, and sterilization validation efforts across R&D, manufacturing, regulation, and clinical programs.

The role requires 10+ years in medical device QA, extensive FDA QSR/ISO knowledge, and the ability to drive CAPA and