Quality Engineer II (medical device)

enableCV; Midvale (UT); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Full benefits

401k match

Paid leave

Job summary

EnableCV is seeking a New Product Development Quality Engineer II in Midvale, UT, to partner across R&D, Regulatory, Manufacturing, and Operations. This on-site role ensures products are developed and launched in compliance with FDA/ISO standards and company procedures.

You will lead risk management per ISO 14971, review design controls, support IQ/OQ/PQ/PPQ validations, and drive continuous improvement while collaborating with cross-functional teams in a regulated 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 device.
• 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 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

Quality Engineering

Regulatory compliance

Risk management

Design controls

Validation

Audit readiness

Education

Bachelor’s degree in Engineering or related technical field

Job description

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

We are a small tight-knit group of go getters that are willing to wear multiple hats, learn quickly, and be flexible in order to grow and develop this business.

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.

Preferred Qualifications

• ASQ CQE certification.
• Six Sigma Green Belt or Black Belt certification.
• Experience with medical devices.
• Quality Mindset
• Technical Excellence
• Accountability

COMPENSATION

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