Quality Engineer II - Medical Devices (Hybrid)

enableCV, LLC; Midvale (UT); Hybrid; USD 100,000 - 130,000; Full time

Job summary

EnableCV, based in Midvale, Utah, is seeking a Quality Engineer II to partner across R&D, Regulatory Affairs, Manufacturing, Supply Chain and Operations to ensure products are developed and launched in compliance with FDA and ISO standards. The role is on-site at headquarters with a flexible hybrid arrangement.

The successful candidate will support new product development, risk management per ISO 14971, design controls, and quality improvements, while contributing to audits, CAPAs and supplier

Qualifications

• Bachelor’s degree in Engineering or related technical field.
• 2+ years of Quality Engineering experience in a regulated industry.
• Experience supporting new product development and design controls.
• Knowledge of FDA regulations, ISO 13485, ISO 14971, CAPA, and validation requirements.
• Strong analytical, communication, and problem-solving skills.

Responsibilities

• Serve as the Quality representative on new product development and sustaining engineering projects.
• Ensure compliance with FDA 21 CFR Part 820/QMSR, ISO 13485, EU MDR 2017/745, and company procedures.
• Lead and facilitate risk management activities in accordance with ISO 14971.
• Review and approve design control documentation, verification and validation activities, and design transfer deliverables.
• Support process validation activities including IQ/OQ/PQ, PPQ and test method validations.
• Support supplier qualification and component quality activities.
• Participate in audits, CAPAs, nonconformance investigations, and change control processes.
• Drive continuous improvement initiatives and analyze quality metrics.

Skills

Analytical skills

Communication

Problem-solving

Quality mindset

Education

Bachelor's degree in Engineering or related field

Job description

EnableCV, based in Midvale, Utah, is seeking a Quality Engineer II to partner across R&D, Regulatory Affairs, Manufacturing, Supply Chain and Operations to ensure products are developed and launched in compliance with FDA and ISO standards. The role is on-site at headquarters with a flexible hybrid arrangement.

The successful candidate will support new product development, risk management per ISO 14971, design controls, and quality improvements, while contributing to audits, CAPAs and supplier