R&D Quality Assurance Engineer II

Job Description

Job Description

R&D Quality Assurance Engineer II

Location : North Barrington, IL

Advance innovation. Ensure quality. Improve lives.

We’re seeking a talented R&D Quality Assurance Engineer to join our dynamic Quality team. In this role, you’ll play an integral part in supporting development projects from concept through production for disposable medical devices— including catheters, catheter-based delivery systems, and other advanced disposable technologies across specialties such as cardiology, neurology, and urology.

You’ll collaborate closely with high-performance, cross-functional teams to design and develop products that meet our mission : delivering safe, effective, and reliable medical devices that meet our customers’ expectations for quality, quantity, and timeliness.

What You’ll Do

Represent Quality on R&D teams, ensuring compliance with internal quality systems and external regulatory standards.

Partner with R&D to implement design controls guided by risk management , customer requirements , and manufacturability .

Develop and maintain Design History Files (DHFs) and Quality Plans for development projects.

Contribute to risk management activities compliant with ISO 14971 .

Review and provide input on design documentation , drawings, material specifications, and manufacturing procedures.

Develop and optimize quality control inspection documentation , including inspection procedures, sample sizes, and metrology selection.

Execute testing activities such as design verification / validation , test method validation , process validation , and lot release testing .

Support nonconformance investigations, CAPAs , and deviation management.

Participate in supplier qualification , define inspection criteria, and monitor material and service quality.

Provide quality input during audits and regulatory inquiries, and assist with customer communication.

Apply systematic problem-solving techniques to identify and resolve quality issues and perform root cause analyses.

Train and mentor technicians and inspectors as needed.

Lead and execute full project deliverables to meet customer expectations and demonstrate mastery of the Design & Development process .

What You Bring

BS or MS in an engineering discipline , or equivalent relevant experience.

2–5 years of experience in Quality Engineering or R&D Engineering within the medical device industry .

Familiarity with ISO 13485 , ISO 14971 , and FDA 21 CFR Part 820 standards.

Experience in design controls , design history files , and medical device testing .

Strong technical writing skills for protocols, reports, and data analysis.

Working knowledge of statistics (SPC, data analysis).

Proficiency with Microsoft Office or equivalent tools.

Excellent communication, analytical, and problem-solving skills.

Green Belt Certification preferred.

Why Join Us

Work with cutting-edge technologies in a collaborative, innovation-driven environment.

Directly contribute to life-improving medical solutions.

Be part of a culture that values quality, accountability, and continuous improvement.

Competitive salary, comprehensive benefits, and opportunities for professional growth.

Be part of a team that’s shaping the future of medical devices.

If you’re ready to elevate your career and make a measurable impact, we’d love to hear from you.

Medical Murray is an equal opportunity employer.