Quality Engineer II (medical device) in Midvale

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

Job Description

EnableCV is based in Midvale, UT and this role will be located on site at the enableCV headquarters.

Position Summary

The New Product Development Quality Engineer II is responsible for providing quality engineering partnership throughout the product development lifecycle for medical devices. This role partners closely with R&D, Regulatory Affairs, Manufacturing, Supply Chain, and Operations to ensure products are developed and launched in compliance with applicable regulations and quality standards.

Essential Duties and 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.

Qualifications

• Bachelor’s degree in Engineering or related technical field.
• 3-5 years of Quality Engineering experience in a regulated industry, preferably medical device.
• 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.

Qualifications

• ASQ CQE certification.
• Six Sigma Green Belt or Black Belt certification.
• Experience with medical devices.

Competencies

• Quality Mindset
• Collaboration
• Technical Excellence
• Continuous Improvement
• Accountability

COMPENSATION

• Base salary (starting at $100k) + annual bonus %+ full benefits package (medical, dental, vision, life insurance, paid leave/maternity/paternity, short/long term , 401k + employer match etc.)

Our people are passionate about what they do, the product they sell, and the customers they serve. If you're looking for an opportunity to be a part of a work family that values collaboration, innovation, dedication, and people, we're the right company for you. We save lives every day and we love it - join us!

Industry: Medical Equipment Manufacturing

Employment Type:Full-time