Senior Quality Engineer - Med Devices & Design Controls

Inquis Medical, Inc.; Menlo Park, Northern (CA, KY); Hybrid; USD 120,000 - 145,000; Full time

Job summary

Inquis Medical, Inc. is seeking a Senior Quality Engineer to lead quality activities across product development and manufacturing, ensuring FDA and ISO 13485 compliance.

You will drive Design Controls, CAPA, and risk management while partnering with Engineering, Operations, Regulatory, and Supply Chain. The role requires 7–10 years in medical device quality, experience with Class II/III devices, and strong project management.

Qualifications

• Bachelor's degree in engineering or related field.
• 7–10 years of quality engineering experience in the medical device industry.
• 5 years supporting FDA-regulated medical device manufacturing.
• Experience leading cross-functional quality initiatives.
• Medical device startup experience.

Responsibilities

• Lead quality engineering activities across product development, manufacturing, supplier quality, and QMS.
• Manage Design Controls including design reviews, verification/validation, and DHF documentation.
• Lead NCR investigations and CAPA activities with timely closure.
• Develop and monitor KPIs and dashboards for QMS effectiveness.
• Collaborate with cross-functional teams to improve processes and product quality.
• Support supplier evaluations, audits, and supplier quality agreements.

Skills

Quality Engineering

Design Controls

FDA Regulations

ISO 13485

Risk Management

DFMEA

PFMEA

Supplier Quality

Change Management

Data Analysis

Education

Bachelor's degree in engineering

Tools

IQ/OQ/PQ

Job description

Inquis Medical, Inc. is seeking a Senior Quality Engineer to lead quality activities across product development and manufacturing, ensuring FDA and ISO 13485 compliance.

You will drive Design Controls, CAPA, and risk management while partnering with Engineering, Operations, Regulatory, and Supply Chain. The role requires 7–10 years in medical device quality, experience with Class II/III devices, and strong project management.