Analyst, Product Surveillance
generis Tek•Plymouth, MN
•Onsite
About The Position
The Product Surveillance Analyst supports post-market surveillance activities by inspecting, testing, and evaluating returned medical devices. The role assists with product complaint investigations through laboratory analyses, documentation of findings, and support for determining device performance characteristics. It requires close attention to detail, adherence to procedures, and accurate documentation in accordance with quality system requirements. This is a 4–6 month contract role based in Plymouth, Minnesota, and is 100% onsite. The listed schedule is Monday through Friday, 8:00 a.m. to 4:30 p.m. The pay rate is $30.50 per hour on W-2.
Requirements
- At least 1 year of experience working in a laboratory environment with hands-on analysis or testing.
- Bachelor's degree in a science, engineering, healthcare, or technical field, or an 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 MS Office applications.
- Effective written and verbal communication skills.
Nice To Haves
- 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.
Responsibilities
- Receive, inspect, and evaluate returned medical devices associated with customer complaints.
- Perform 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.
