R&D Quality Assurance Engineer (Medical Devices)

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

Benefits offered by this job

Medical and dental coverage

Vision and life insurance

Disability insurance

HSA-eligible plans

401(k) Safe Harbor

PTO

TeleDoc access

Tuition reimbursement

Volunteer time off

Job summary

Medical Murray is seeking an Associate R&D Quality Assurance Engineer to support development projects from concept to production for disposable medical devices, including catheters and delivery systems.

You will work with cross-functional teams to meet quality, quantity, and timeliness goals while complying with ISO 13485/14971 and FDA 21 CFR 820. Strong documentation and testing skills are essential.

Qualifications

• Knowledge of ISO-13485, ISO-14971, and FDA 21 CFR Part 820 cGMP standards.
• Experience with design control and design history files.
• Green Belt Certification is a plus.

Responsibilities

• Understand quality standards and regulatory requirements for medical devices.
• Represent Quality on development teams to ensure QMS compliance.
• Develop and update Design History Files on behalf of customers.
• Create and maintain Quality Plans for development projects.
• Contribute to risk management activities per ISO 14971.
• Review documentation to ensure manufacturability and quality.
• Perform inspections and assist in test protocols and verification/validation.

Skills

ISO-13485

ISO-14971

FDA 21 CFR Part 820

Quality testing

Design controls

Statistical analysis

SPC

Documentation skills

Communication skills

Problem solving

Education

BS/MS in engineering or equivalent

Job description

Medical Murray is seeking an Associate R&D Quality Assurance Engineer to support development projects from concept to production for disposable medical devices, including catheters and delivery systems.

You will work with cross-functional teams to meet quality, quantity, and timeliness goals while complying with ISO 13485/14971 and FDA 21 CFR 820. Strong documentation and testing skills are essential.