R&D QA Engineer – Medical Devices

Medical Murray; North Barrington (IL); On-site; USD 65,000 - 75,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision insurance

Short-term disability

401(k) plan

PTO and volunteering leave

TeleDoc access

Tuition reimbursement

Job summary

Medical Murray in North Barrington, IL is seeking an Associate R&D Quality Assurance Engineer to support development projects for disposable medical devices, including catheters and delivery systems. This role collaborates with cross-functional teams to meet quality, quantity, and timeliness requirements.

You will work to ensure compliance with ISO 13485, FDA 21 CFR 820, and design controls, assisting in risk management, design history files, testing, and process validation.

Qualifications

• BS or MS in an engineering discipline or equivalent experience.
• 0–2 years of experience in Quality Engineering or R&D engineering for medical devices.
• Experience with ISO and FDA Quality Systems preferred.
• Experience with design control and establishment of design history files desired.
• Green Belt Certification desired.

Responsibilities

• Understand quality and regulatory standards and requirements.
• Represent Quality on development teams to ensure QMS compliance.
• Partner with R&D to apply design controls based on risk and manufacturability.
• Develop and update Design History Files for customers.
• Create and maintain Quality Plans for development projects.
• Contribute to risk management activities aligned with ISO 14971.
• Review manufacturing documentation for producibility and quality.
• Develop quality control documentation and sampling plans.
• Perform inspections on manufactured products.
• Assist in creating test protocols and perform verification/validation testing.
• Train technicians and inspectors as needed.
• Participate in supplier selection and inbound inspection criteria.

Skills

Quality engineering

R&D engineering

Regulatory compliance

Design controls

Statistical analysis

Documentation

Root cause analysis

Education

BS or MS in engineering or equivalent

Green Belt Certification

Job description

Medical Murray in North Barrington, IL is seeking an Associate R&D Quality Assurance Engineer to support development projects for disposable medical devices, including catheters and delivery systems. This role collaborates with cross-functional teams to meet quality, quantity, and timeliness requirements.

You will work to ensure compliance with ISO 13485, FDA 21 CFR 820, and design controls, assisting in risk management, design history files, testing, and process validation.