Sr. Quality Engineer - Complaints & CAPA (Medical Devices)

The Mullings Group; Itasca (IL); On-site; USD 90,000 - 120,000; Full time

Job summary

Organ Recovery Systems in Itasca, IL is seeking a Quality Engineer for Complaints and CAPA to lead investigations of returned and field-reported devices and drive improvements. This individual contributor role reports to the Managing Director, Regulatory and Quality.

You will collaborate across Engineering, Regulatory, Manufacturing and suppliers to triage, investigate and close out CAPAs, with a focus on risk management and FDA compliance in a fast-paced medical device environment.

Qualifications

• Bachelor's degree in engineering or science required.
• 4+ years medical device quality experience (complaints, CAPA, MDR).
• Experience with capital equipment, sterile products, packaging or labeling.

Responsibilities

• Investigate and document complaints for capital equipment, disposables and serviced devices.
• Triage complaints with Helpline, Engineering and Manufacturing to set scope, risk and escalation.
• Escalate safety concerns quickly and support regulatory reporting decisions.
• Lead CAPAs arising from complaint investigations and trends.
• Run the Complaint Review Board and support CAPA Review Board.
• Build complaint and CAPA metrics for management review and post-market surveillance.
• Support risk management files and internal/external audits and FDA inspections.

Skills

Root cause analysis

Audit-ready writing

Cross-functional

Statistical methods

Education

Bachelor's degree in engineering or science

Tools

Statistical software

Electronic QMS tools

Job description

Organ Recovery Systems in Itasca, IL is seeking a Quality Engineer for Complaints and CAPA to lead investigations of returned and field-reported devices and drive improvements. This individual contributor role reports to the Managing Director, Regulatory and Quality.

You will collaborate across Engineering, Regulatory, Manufacturing and suppliers to triage, investigate and close out CAPAs, with a focus on risk management and FDA compliance in a fast-paced medical device environment.