Remote Senior Design QA Engineer - Medical Devices

Enhanced Compliance Inc.; United States; Remote; USD 110,000 - 150,000; Full time

Job summary

Enhanced Compliance Inc. is seeking an experienced Quality Assurance professional to lead design control gap assessments and drive regulatory compliance for medical devices in a fully remote role across the United States.

You will develop quality documentation, support CAPA/NCR processes, and provide input on Design Change Analysis, Design Inputs/Outputs, Test Methods, and V&V to support project teams from concept to commercialization.

Qualifications

• 5–10 years direct R&D experience in medical device industry.
• Experience in ops quality and design quality.
• Excellent written and verbal communication skills with good presentation and technical writing skills.
• Collaborative attitude with the ability to work well in a team environment.
• Strong engineering, design, and analysis skills for medical devices from concept to commercialization.
• Understanding of FDA Quality Systems Regulations (QSR).
• Familiarity with quality tools and methodologies including SPC, DOE, GR&R, FMEA, CAPA and process validation.

Responsibilities

• Lead design control gap assessments and define critical inputs/outputs.
• Develop quality documentation such as quality plans, SOPs, and inspection procedures.
• Provide regulatory input to project teams for decisions and deliverables (e.g., Design Change Analysis, Design Inputs/Outputs, Test Methods).
• Support CAPA/NCRs/Complaints and participate in design reviews, V&V, usability testing, and process validation.

Skills

R&D experience

Ops quality

Design quality

Communication skills

Team collaboration

FDA QSRs

Quality tools

Tools

SPC

DOE

GR&R

FMEA

CAPA

IQ/OQ/PQ

Job description

Enhanced Compliance Inc. is seeking an experienced Quality Assurance professional to lead design control gap assessments and drive regulatory compliance for medical devices in a fully remote role across the United States.

You will develop quality documentation, support CAPA/NCR processes, and provide input on Design Change Analysis, Design Inputs/Outputs, Test Methods, and V&V to support project teams from concept to commercialization.