Analyst, Product Surveillance

the Client•Plymouth, MN

2d•Onsite

About The Position

The Product Surveillance Analyst supports post-market surveillance activities by inspecting, testing, and evaluating returned medical devices. The analyst assists with product complaint investigations through laboratory analyses, documentation of findings, and evaluation of device performance characteristics. The role requires attention to detail, adherence to approved procedures, and accurate documentation within quality system requirements. The position is onsite in Plymouth, Minnesota, and is approximately 50% laboratory work and 50% desk work, with up to 10% of time spent in meetings. The contract is for five months, with potential to convert to a full-time position.

Requirements

Bachelor's degree in a science, engineering, healthcare, or technical field, or an equivalent combination of education and relevant experience.
At least 1 year of experience working in a laboratory environment with hands-on analysis or testing.
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.
Ability to work in a laboratory environment, handle and inspect small medical device components, and sit, stand, and use laboratory equipment for extended periods.

Nice To Haves

Experience in the medical device industry.
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 with electronic quality management systems such as EPIQ or similar complaint handling databases.
Problem-solving and critical-thinking ability to assess allegations, evaluate them in a laboratory setting, and determine whether testing can confirm them.
Root cause analysis ability, including following a methodology and testing template to identify likely root causes and failure modes.
Electrical aptitude to understand device operation, read manufacturing prints, and determine testing against specifications.

Responsibilities

Receive, inspect, and evaluate returned medical devices associated with customer complaints.
Conduct 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 to support evaluations.
Maintain compliance with FDA regulations, quality system requirements, and internal procedures.
Collaborate with engineers, analysts, and quality personnel on complaint investigations and post-market surveillance activities.
Complete assigned investigations on time while meeting quality and productivity expectations.
Participate in continuous improvement initiatives and support laboratory organization and maintenance.