Quality Engineer

Role:
Quality Engineer

Location: West Valley City, UT (100% Onsite)

Duration: 12+ Months

We are seeking an experienced Quality Engineer to support design quality, integration, and remediation initiatives within a regulated medical device environment. This role requires strong technical expertise in Design Controls, Risk Management, Verification & Validation (V&V), and Technical Risk Management (TRM/TMV), with the ability to independently develop, execute, and support quality engineering activities throughout the product lifecycle.

• Support New Product Development (NPD) and Design Quality activities in compliance with FDA 21 CFR Part 820 and applicable quality standards.
• Lead and support Design History File (DHF) remediation and design integration projects.
• Develop and execute risk management activities, including risk assessments, hazard analyses, and mitigation strategies.
• Author and review design control documentation, V&V protocols, reports, and technical files.
• Support implementation of Design for Manufacturability (DFM) principles and quality improvements.
• Collaborate with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Quality.
• Participate in major remediation and integration initiatives to ensure compliance and product quality.
• Support design transfer, change management, and lifecycle management activities.

• Bachelor's degree in Engineering or a related technical discipline.
• 4+ years of Quality Engineering experience within the medical device industry.
• Strong experience with Design Controls and FDA 21 CFR Part 820 requirements.
• Hands‑on experience developing and executing Risk Management and Verification & Validation (V&V) activities.
• Experience supporting design integration, DHF remediation, and quality system improvement initiatives.
• Strong technical writing, problem‑solving, and cross‑functional collaboration skills.