Med Device Product Surveillance Analyst

Abbott; Plymouth (MN); Sur place; USD 55 000 - 75 000; Plein temps

Avantages offerts par ce poste

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Flexible Spending Accounts

Supplemental Life Insurance

Short Term Disability

Long Term Disability

Critical Illness, Hospital coverage, &

Résumé du poste

Abbott in Plymouth, MN is seeking an Analyst for Product Surveillance to support post-market surveillance through inspection, testing, and evaluation of returned medical devices. The role involves documenting findings and supporting device performance investigations in a regulated environment.

The position requires meticulous documentation, adherence to procedures, and effective collaboration with engineers and quality teams to ensure timely completion of investigations and compliance with

Qualifications

• Bachelor's degree in a science, engineering, healthcare, or technical field, or equivalent experience.
• Strong attention to detail and ability to document results.
• Experience with lab settings and hands-on analysis/testing is desired.

Responsabilités

• Perform receipt, inspection, and evaluation of returned medical devices linked to customer complaints.
• Conduct laboratory testing and product performance evaluations per work instructions.
• Document observations and results in complaint handling systems and lab records.
• Support root cause investigations by analyzing product performance data.
• Operate lab equipment safely and effectively.
• Review device history information and specifications to support evaluations.
• Maintain compliance with FDA regulations and internal procedures.
• Collaborate with engineers, analysts, and quality personnel on investigations.

Connaissances

Lab testing

Data analysis

Attention to detail

Communication skills

Formation

Bachelor's degree in science/engineering/healthcare or related

Outils

Microsoft Office

Quality systems

EPIQ

Description du poste

Abbott in Plymouth, MN is seeking an Analyst for Product Surveillance to support post-market surveillance through inspection, testing, and evaluation of returned medical devices. The role involves documenting findings and supporting device performance investigations in a regulated environment.

The position requires meticulous documentation, adherence to procedures, and effective collaboration with engineers and quality teams to ensure timely completion of investigations and compliance with