Analyst, Product Surveillance

Abbott; Plymouth (MN); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

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, &

Job summary

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.

Responsibilities

• 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.

Skills

Lab testing

Data analysis

Attention to detail

Communication skills

Education

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

Tools

Microsoft Office

Quality systems

EPIQ

Job description

Title: Analyst, Product Surveillance

Location: Plymouth, MN

Duration: 6 Months

Shifts: 8am - 4pm

100% Onsite

Summary

The Product Suveillance Analyst supports post-market surveillance activities through the inspection, testing, and evaluation of returned medical devices. This position assists in product complaint investigations by performing laboratory analyses, documenting findings, and supporting the determination of device performance characteristics. The role requires strong attention to detail, adherence to procedures, and accurate documentation within quality system requirements.

Key Responsibilities

• Perform receipt, inspection, and evaluation of returned medical devices associated with customer complaints.
• Execute laboratory testing and product performance evaluations according to approved work instructions and procedures.
• Document observations, test results, and investigation findings in complaint handling systems and laboratory records.
• Support root cause investigations by gathering and analyzing product performance data.
• Operate laboratory equipment, tools, and test fixtures safely and effectively.
• Review device history information, investigation records, and product specifications as needed to support evaluations.
• Maintain compliance with FDA regulations, quality system requirements, and internal procedures.
• Collaborate with engineers, analysts, and quality personnel to support complaint investigations and post-market surveillance activities.
• Ensure timely completion of assigned investigations while meeting quality and productivity expectations.
• Participate in continuous improvement initiatives and support laboratory organization and maintenance activities.

Required Qualifications

• A minimum of 1 year experience in working in a lab environment with hands on analysis/testing (preferreably in med-device industry but open to any others).
• Bachelor's degree in a science, engineering, healthcare, or technical field; or equivalent combination of education and relevant experience.
• Strong attention to detail and organizational skills.
• Ability to follow detailed procedures and accurately document results.
• Basic computer skills, including experience with Microsoft Office applications.
• Effective written and verbal communication skills.

Preferred Qualifications

• Experience in the medical device, pharmaceutical, biotechnology, or regulated manufacturing industry.
• Experience performing laboratory testing, product analysis, troubleshooting, or complaint investigations.
• Familiarity with FDA Quality System Regulations (21 CFR Part 820), complaint handling, and post-market surveillance processes.
• Experience working with electronic quality management systems such as EPIQ or similar complaint handling databases.

Physical Requirements

• Ability to work in a laboratory environment.
• Ability to handle and inspect small medical device components.
• Ability to sit, stand, and use laboratory equipment for extended periods.

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.