Principal Quality Engineer

Meet Life Sciences Ltd.; San Jose (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Meet Life Sciences Ltd. in San Jose, CA, seeks a Senior Quality Assurance Engineer to own the QMS and ensure regulatory compliance for medical devices.

You will drive quality improvements and partner with CEO, engineering, and manufacturing to support both existing products and new device development. This hands-on, IC role requires leading FDA inspections, audits, CAPA programs, and post-market activities while maintaining robust document control and risk management.

Qualifications

• Minimum 8 years of quality experience within the medical device industry.
• Experience taking ownership of a medical device QMS and day-to-day quality operations.
• Proven experience leading FDA inspections and ISO 13485 audits.
• Strong knowledge of FDA 21 CFR Part 820 (QMSR), ISO 13485 and ISO 14971.
• CAPA, complaint handling, nonconformance investigations, supplier quality and document control experience.
• Design controls, risk management, verification and validation, IQ/OQ/PQ in manufacturing environments.
• Excellent analytical, problem-solving and cross-functional collaboration skills.

Responsibilities

• Own the QMS ensuring FDA QMSR and ISO 13485 compliance.
• Lead FDA inspections and audits and manage corrective actions.
• Drive CAPA and nonconformance investigations.
• Oversee post-market quality activities and regulatory reporting.
• Collaborate with engineering on design controls, verification and validation, risk assessments and documentation.
• Manage supplier quality processes and audits.
• Support manufacturing quality via process validation and release activities.
• Maintain document control and change management.
• Monitor quality performance and report to senior leadership.

Skills

QMS ownership

FDA inspections

ISO 13485 audits

Regulatory compliance

CAPA

Risk management

Design controls

IQ/OQ/PQ

Statistical analysis

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Life Sciences

Tools

eQMS

Job description

Senior Quality Assurance Engineer | Medical Devices

We are partnering with an innovative, commercial-stage medical device company specialising in advanced imaging technologies to recruit a Senior Quality Assurance Engineer.

This is an opportunity for an experienced quality professional to take complete ownership of the company's Quality Management System (QMS), ensuring regulatory compliance while supporting the continued commercialisation and development of innovative medical technologies.

Working closely with the CEO, engineering and manufacturing teams, you will play a pivotal role in driving quality standards, strengthening processes and supporting both existing commercial products and future device development.

This is a hands-on, individual contributor position suited to someone who enjoys autonomy, thrives in a smaller organisation and has proven experience managing quality systems within a regulated medical device environment.

Key Responsibilities

• Take ownership of the company's QMS, ensuring ongoing compliance with FDA QMSR (21 CFR Part 820) and ISO 13485 requirements.
• Act as the primary quality representative during FDA inspections, notified body or third-party audits, managing preparation, inspection activities and subsequent corrective actions.
• Drive quality investigations and improvement initiatives, including CAPA, nonconformance management and root cause analysis.
• Oversee post-market quality activities, including product complaints, regulatory reporting assessments and quality trend monitoring.
• Partner with engineering teams on design control activities, product verification and validation, risk assessments and technical documentation.
• Manage supplier quality processes, including qualification, performance monitoring, audits and corrective actions.
• Support manufacturing quality through process validation, inspection strategies, sampling methodologies and product release activities.
• Maintain effective document control, change management, training and calibration processes.
• Monitor quality performance, identify opportunities for improvement and communicate key findings to senior leadership.

Key Requirements

• Bachelor's degree in Engineering, Life Sciences or a related technical field.
• Minimum 8 years of quality experience within the medical device industry, ideally supporting commercially marketed products.
• Demonstrated experience taking ownership of a medical device QMS, with the ability to independently manage day-to-day quality operations.
• Proven experience leading FDA inspections and ISO 13485 audits, including direct engagement with inspectors and managing audit findings through resolution.
• Strong understanding of FDA 21 CFR Part 820 (QMSR), ISO 13485 and ISO 14971, alongside relevant post-market regulatory requirements.
• Practical experience across CAPA, complaint handling, nonconformance investigations, supplier quality and document control.
• Familiarity with medical device design controls, risk management, verification and validation, and manufacturing process validation (IQ/OQ/PQ).
• Strong analytical and problem-solving capabilities, including experience applying statistical techniques to quality processes.
• Confident communicator with the ability to work cross-functionally, manage competing priorities and operate independently.

Additional Experience of Interest

• Quality engineering experience involving catheter-based, optical imaging or electromechanical medical devices.
• Knowledge of sterilisation processes, biocompatibility testing and ISO 10993.
• Familiarity with IEC 60601 and supporting FDA 510(k) regulatory submissions.
• Experience implementing, maintaining or improving electronic Quality Management Systems (eQMS).
• Previous experience within a medical device startup or smaller organisation, particularly where you have helped establish or scale quality processes.

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