Senior Quality Engineer - Medical Devices (FDA/ISO)

Inquis Medical, Inc.; San Francisco (CA); On-site; USD 120,000 - 145,000; Full time

Job summary

Inquis Medical, Inc. is seeking a Senior Quality Engineer to lead quality engineering across development, manufacturing, and supplier quality.

You will partner with Engineering, Regulatory and Operations to ensure FDA/ISO 13485 compliance and robust risk management throughout the product lifecycle. The role emphasizes QMS optimization, CAPA leadership, and cross-functional collaboration to deliver high-quality medical devices in a fast-paced environment.

Qualifications

• Bachelor's degree in Mechanical/Biomedical/Manufacturing/Industrial Quality Engineering or related field.
• 7–10 years of Quality Engineering experience in medical devices.
• Experience supporting FDA-regulated manufacturing and NPD.

Responsibilities

• Lead quality engineering activities across product development, manufacturing and supplier quality.
• Maintain and improve the QMS, SOPs, records and quality metrics.
• Lead design assurance activities per 21 CFR 820/ISO 13485 and risk management per ISO 14971.
• Coordinate CAPA, NCR investigations, and corrective actions with cross-functional teams.
• Analyze quality data, drive Lean and Continuous Improvement initiatives.
• Engage in supplier evaluations, audits, and performance reviews.

Skills

Quality engineering

Project management

Analytical thinking

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Mechanical Engineering

Job description

Inquis Medical, Inc. is seeking a Senior Quality Engineer to lead quality engineering across development, manufacturing, and supplier quality.

You will partner with Engineering, Regulatory and Operations to ensure FDA/ISO 13485 compliance and robust risk management throughout the product lifecycle. The role emphasizes QMS optimization, CAPA leadership, and cross-functional collaboration to deliver high-quality medical devices in a fast-paced environment.