RCI-ABO-48810 Product Suveillance Analyst

Apply Here: https://talentarbor.com/job/details/142342/3/190/product-surveillance-analyst-plymouth-mn-us

Fully Onsite Role

Schedule: 8 am - 4 pm (Monday - Friday)

Position 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.

Assignment Overview

How long is the assignment? 4 to 6 months

Is there potential for the role to convert to a full-time Client position? Possibly

Work Location & Schedule

Is the role onsite, hybrid, or remote? Onsite

Where is the assignment located? Plymouth, MN

What are the working hours (e.g., 8/40)? 8/40 M-F (8AM – 430PM)

Will travel be required? If so, how often and where? No

Top 3 preferred skills:

Preferred Skill Tool / Technology / System Value to the Role (Nice-to-have vs Strong Advantage) Willing to Flex? (Yes / No)

• Problem Solving Critical thinking (what is being alleged, what does that look like in lab, are we able to confirm the allegation) Strong advantage Take the guideline of the specific allegation and perform electrical testing to confirm/unconfirm the reported issue
• Root Cause Analysis Work through a methodology to come to a likely root cause Strong advantage Able to follow a template for testing and determine the likely failure mode
• Electrical Aptitude Able to understand how the device works to be able to perform testing.
• Strong advantage Able to read a manufacturing print and understand the testing that needs to be performed against certain specifications.

Are there any certification or education requirements? 4-year STEM degree

Does the candidate need experience in the medical or pharmaceutical industry? Experience in the medical device industry preferred

What systems will this person be working with daily? Windows OS, Lecia microscopes, EPIQ complaint handling system, and various testing equipment.

What personality traits work best with your team? Ability to work independently and cross-functionally as needed to complete testing, collaborative, driven, self-starter