Senior Quality Engineer, Medical Devices — NPD & Compliance

Willow Laboratories, Inc.; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Willow Laboratories, Inc. in Irvine, CA is seeking a Senior Quality Engineer with deep expertise in medical device QMS to lead quality assurance across new product development and manufacturing scale-up.

In this on-site role, you will drive risk management, CAPA, supplier quality, and regulatory submissions, ensuring compliance with ISO 13485, ISO 14971, and FDA QSMR, while fostering a culture of quality.

Qualifications

• BS or higher in Biomedical, Electrical, Chemical, Mechanical, or Systems Engineering.
• 10+ years of QA experience in the medical device industry.
• Expert-level knowledge of ISO 13485, ISO 14971, FDA QSMR, and GMP.
• Experience with cleanroom manufacturing, sterilization (EtO), and GD&T interpretation.
• Proficiency in root cause investigation tools (Fishbone, 5 Why) and statistical software (Minitab, JMP).
• Excellent problem-solving, communication, and teamwork; travel up to 15%.
• Master’s degree and CQE or similar certifications desirable.

Responsibilities

• Drive Quality Engineering activities throughout NPD for electro-mechanical devices and wearables.
• Lead risk assessment efforts (FMEA, URRA, Hazard Analysis) and Master Validation Plans.
• Support regulatory submissions (FDA Q-sub, 510(k), PMA) and defend processes during audits.
• Develop and maintain QMS processes (SOPs, work instructions) per ISO 13485/17025 and FDA QSMR.
• Reduce manufacturing defects through CAPA investigations and corrective actions.
• Oversee product/process validations, method development, and Metrology program.
• Manage supplier development, conduct supplier quality audits, ensure compliance.
• Foster a proactive Culture of Quality via cross-functional collaboration.

Skills

Quality Assurance

QA in medical devices

ISO 13485 knowledge

ISO 14971 knowledge

FDA QSMR knowledge

CAPA

FMEA

Root cause analysis

Minitab

JMP

GMP

Audit readiness

GD&T understanding

Regulatory submissions

Education

BS in Biomedical, Electrical, Chemical, Mechanical, or Systems Engineering

Master’s degree (desired)

Tools

Minitab

JMP

Job description

Willow Laboratories, Inc. in Irvine, CA is seeking a Senior Quality Engineer with deep expertise in medical device QMS to lead quality assurance across new product development and manufacturing scale-up.

In this on-site role, you will drive risk management, CAPA, supplier quality, and regulatory submissions, ensuring compliance with ISO 13485, ISO 14971, and FDA QSMR, while fostering a culture of quality.