QMS Lead - Medical Devices, FDA/ISO 13485 Expert

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

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.