Remote Senior Design QA Engineer – Medical Devices

Theuniversityunion; United States; Remote; USD 90,000 - 125,000; Full time

Job summary

ECI is a remote role focused on quality and regulatory responsibilities within medical device development. The major tasks include design control gap assessments, risk management, and ensuring that design inputs, outputs, test methods, and validation activities meet current standards.

You will develop quality documentation, participate in design reviews, and provide guidance on CAPA, NCRs, and complaints to project teams. Strong FDA/ISO knowledge and communication skills are essential.

Qualifications

• 3–5 years of direct R&D experience in medical devices.
• Experience with capital equipment; single-use devices preferred.
• Strong knowledge of FDA QSR, ISO 13485, 14971, and 21 CFR 820.
• Excellent written and verbal communication and technical writing.
• Ability to work in a team and lead quality initiatives.

Responsibilities

• Design control gap assessment.
• Define design inputs and risk management activities.
• Provide quality input to project teams for decisions and deliverables.
• Develop quality documentation and ensure regulatory compliance.
• Lead quality initiatives during design reviews and V&V.
• Support CAPA/NCRs/Complaints.
• Assist with special projects as needed.

Skills

Quality assurance

Regulatory compliance

Statistical analysis

Documentation

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

SPC

DOE

GR&R

CAPA

Process validation

Job description

ECI is a remote role focused on quality and regulatory responsibilities within medical device development. The major tasks include design control gap assessments, risk management, and ensuring that design inputs, outputs, test methods, and validation activities meet current standards.

You will develop quality documentation, participate in design reviews, and provide guidance on CAPA, NCRs, and complaints to project teams. Strong FDA/ISO knowledge and communication skills are essential.