Quality Engineer II – Medical Devices, NPD & Compliance

Energy Jobline ZR; Midvale (UT); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Paid leave

401k + employer match

Job summary

EnableCV, headquartered in Midvale, UT, seeks a New Product Development Quality Engineer II to partner with R&D, Regulatory Affairs, Manufacturing and Operations. You will ensure products are developed and launched in compliance with FDA, ISO 13485 and EU MDR, driving risk management and design verification throughout the lifecycle.

The role emphasizes design controls, supplier quality, CAPAs and continuous improvement in a medical device environment.

Qualifications

• Bachelor’s degree in Engineering or related technical field.
• 3–5 years of Quality Engineering experience in a regulated industry, preferably medical devices.
• Experience supporting new product development and design controls.
• Knowledge of FDA regulations, ISO 13485, ISO 14971, CAPA and validation requirements.

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 risk management activities in accordance with ISO 14971.
• Review and approve design control documentation, verification/validation activities, and design transfer.
• 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

Quality engineering

Regulatory understanding

Analytical thinking

Education

Bachelor's degree in Engineering

ASQ CQE certification

Job description

EnableCV, headquartered in Midvale, UT, seeks a New Product Development Quality Engineer II to partner with R&D, Regulatory Affairs, Manufacturing and Operations. You will ensure products are developed and launched in compliance with FDA, ISO 13485 and EU MDR, driving risk management and design verification throughout the lifecycle.

The role emphasizes design controls, supplier quality, CAPAs and continuous improvement in a medical device environment.