Product Surveillance Analyst (Saint Paul)

Primary Job Title :

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Product Surveillance Analyst

Alternate / Related Job Titles :

Product Performance Analyst

Complaint Investigation Specialist

Product Experience Analyst

Quality Systems Analyst

Post-Market Surveillance Specialist

Location : St. Paul, MN

Onsite Flexibility : Onsite

Contract Details :

Position Type : Contract

Contract Duration : 12 months

Start : As Soon As Possible

Pay Rate : $31.91 / hr

Schedule : MondayFriday, 8 : 00 AM5 : 00 PM

Job Summary :

The Product Surveillance Analyst plays a critical role in managing product performance investigations and ensuring compliance with global regulatory requirements. This position involves evaluating product complaints, performing root-cause analysis, managing returned product testing, and maintaining accurate documentation in the complaint database. The role supports internal and external audits, trending, and cross-functional communication to maintain the company's high quality and compliance standards.

Key Responsibilities :

Manage and maintain product experience investigations and associated documentation.

Receive, log, and triage incoming product experience reports.

Conduct investigations and testing of returned medical devices or components, ensuring proper documentation and safe handling practices.

Review and interpret technical product specifications, Device History Records (DHRs), and test results.

Record inspection details, condition reports, and photographic evidence for each case.

Communicate findings and request additional information from physicians, hospital personnel, and international affiliates as needed.

Independently assess whether events require Medical Device Reporting (MDR) to the FDA or other regulatory authorities.

Evaluate complaints to determine escalation requirements and ensure timely reporting.

Support internal audits, inspections, and legal requests related to product complaints.

Collaborate with cross-functional teams (Quality Engineering, R&D, Medical Affairs) to identify trends and support root cause analysis.

Contribute to Quality Management System (QMS) and Environmental Management System (EMS) compliance initiatives.

Maintain and update procedures and work instructions to reflect current practices.

Required Experience :

Bachelor's degree in a science, engineering, or technical field.

13 years of experience in product complaint handling, post-market surveillance, or medical device quality systems.

Knowledge of FDA and international regulatory reporting requirements.

Understanding of GMP, QSR, and ISO 13485 standards.

Strong written and verbal communication skills with attention to detail.

Nice-to-Have Experience :

Experience in medical device complaint management or product analysis.

Familiarity with SAP, TrackWise, or complaint handling databases.

Experience participating in regulatory audits (FDA, BSI, TUV).

Required Skills :

Product Complaint Investigation

Root Cause Analysis

Regulatory Reporting (MDR / Global)

Preferred Skills :

Laboratory Testing and Data Evaluation

Cross-Functional Collaboration

Technical Writing and Documentation

Additional Skills :

Device testing and product evaluation

Complaint trending and data analysis

Quality and compliance auditing support

Benefits :

Medical, Vision, and Dental Insurance Plans

401k Retirement Fund

About the Client :

Global Healthcare Innovator A leading healthcare company dedicated to improving lives worldwide. With a diverse portfolio of medical devices, diagnostics, nutrition products, and branded generics, the organization focuses on developing groundbreaking technologies that empower people to live healthier, longer lives.

Join the team and :

Work on cutting-edge projects

Contribute to global healthcare advancements

Experience diverse cultures and geographies

Discover a rewarding career with a company that cares

About GTT :

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. As a Native American-owned, economically disadvantaged corporation, we highly value diverse and inclusive workplaces. Our clients are Fortune 500 banking, insurance, financial services, and technology companies, along with some of the nation's largest life sciences, biotech, utility, and retail companies across the US and Canada. We look forward to helping you land your next great career opportunity!

Job Number : 25-27379

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