Remote Quality Engineer II — Medical Devices & Compliance

Theuniversityunion; California (MO); Hybrid; USD 95,000 - 130,000; Full time

Job summary

ECI seeks a Quality professional with hands-on R&D experience in the medical device field to lead design control and regulatory activities. You will assess design controls, risk management, and test methods, ensuring FDA/ISO compliance across the product lifecycle.

You’ll develop quality plans, participate in design reviews, and guide CAPA and process validation. Strong communication, teamwork, and a solid understanding of FDA 21 CFR 820, ISO 13485, 14971, and 11607 are required.

Qualifications

• 3–5 years of direct R&D experience in medical devices.
• Experience with durable medical capital equipment and single-use devices preferred.
• Excellent written and verbal communication with presentation and technical writing skills.
• Understanding of FDA Quality Systems Regulations.
• Knowledge of FDA 21 CFR 820, ISO 13485, 14971, 11607.

Responsibilities

• Lead design control gap assessments and risk management activities.
• Contribute to quality and compliance decisions (e.g., Design Change Analysis, Design Inputs/Outputs, Test Methods, D&V).
• Develop quality documentation and ensure FDA/ISO compliance.
• Represent quality in design and phase reviews; lead CAPA/NCR activities.
• Support acceptance activities, sampling plans, and process validation.
• Apply statistical approaches (DOE, SPC) and teach their use to teammates.

Skills

R&D experience

Quality tools

Team player

Tools

SPC

DOE

GR&R

FMEA

CAPA

Process validation

Job description

ECI seeks a Quality professional with hands-on R&D experience in the medical device field to lead design control and regulatory activities. You will assess design controls, risk management, and test methods, ensuring FDA/ISO compliance across the product lifecycle.

You’ll develop quality plans, participate in design reviews, and guide CAPA and process validation. Strong communication, teamwork, and a solid understanding of FDA 21 CFR 820, ISO 13485, 14971, and 11607 are required.