Quality Engineer – Medical Devices & Compliance

Spiro Robotics, Inc.; Hayward (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Spiro Robotics, Inc. is seeking a Quality Engineer to oversee quality engineering activities for medical devices, including NPD quality, CAPA, deviations, risk management, and supplier quality.

The role emphasizes compliance with FDA requirements and ISO standards, with opportunities to influence device safety and performance. Ideal candidates will have a Bachelor's in Engineering and at least 2 years of quality experience in the medical device sector, strong documentation skills, and the

Qualifications

• Bachelor's degree in Engineering required, with minimum 2+ years in quality engineering for medical devices.
• Experience with FDA Class II devices with software is required.
• Familiarity with ISO 13485, ISO 14971, and Canadian Medical Devices Regulations is expected.
• Knowledge of US medical device regulatory requirements and risk management techniques.
• Strong communication skills and ability to work independently and in teams.

Responsibilities

• Ensure compliance with quality system requirements and regulatory standards.
• Manage quality engineering activities across NPD, CAPA, deviations, risk management, QM files, and supplier quality.
• Develop, review, and approve test protocols and reports (DVR, packaging, sterilization validation).
• Perform internal and supplier quality audits and manage the risk management program.
• Provide QA support to product development, manufacturing, complaints, and service activities.
• Coordinate training on quality system awareness and new hire onboarding.
• Review service records and manage LHR review and approval process.

Skills

FDA regulations

ISO 13485/14971

Risk management

CAPA & Deviations

Quality audits

Documentation

Cross-functional collaboration

Test protocols & reports

Education

Bachelor's degree in Engineering

Tools

Microsoft Word

Microsoft Excel

Job description

Spiro Robotics, Inc. is seeking a Quality Engineer to oversee quality engineering activities for medical devices, including NPD quality, CAPA, deviations, risk management, and supplier quality.

The role emphasizes compliance with FDA requirements and ISO standards, with opportunities to influence device safety and performance. Ideal candidates will have a Bachelor's in Engineering and at least 2 years of quality experience in the medical device sector, strong documentation skills, and the