Quality Engineer II (medical device)

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

The 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.

This exciting opportunity will support an independent medical device company, enableCV. EnableCV is based in Midvale, Utah and this role will be located on site at the enableCV headquarters. This is a flexible hybrid, mostly on-site role, which will thrive in a collaborative, start up like environment. We are a small tight-knit group of go getters that are willing to wear multiple hats, learn quickly, and be adaptable and flexible to grow and develop our existing business.

Key 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.

Required Qualifications:

• Bachelor’s degree in Engineering or related technical field.
• 2+ 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.
• Medical device experience strongly preferred.
• Experience supporting the development of regulated devices outside of medical device industry.
• Quality Mindset
• Technical Excellence
• Accountability

Compensation:

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

Our people are passionate about what they do, the products 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, hybrid schedule (3 days in office minimum)