What are the responsibilities and job description for the Product Surveillance Analyst position at GForce Life Sciences?
Product Surveillance Analyst
6 month contract
Must be able to work on a W2
On-site in Plymouth, MN
SUMMARY
Our client, a medical device company, has engaged GForce Life Sciences to provide a Product Surveillance Analyst. This position supports post-market surveillance activities through inspection, testing, and evaluation of returned medical devices. The role involves assisting in product complaint investigations, documenting findings, and supporting determination of device performance characteristics.
DUTIES / EXPECTATIONS OF ROLE
- Perform receipt inspection and evaluation of returned medical devices related to 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 investigations while meeting quality and productivity standards.
- Participate in continuous improvement initiatives and laboratory organization activities.
MANDATORY REQUIREMENTS
- Minimum of 1 year experience in a laboratory environment with hands-on analysis/testing, preferably in the medical device industry but open to other regulated environments.
- 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 Microsoft Office applications.
- Effective written and verbal communication skills.
NICE TO HAVE
- Experience in the medical device, pharmaceutical, biotechnology, or regulated manufacturing industries.
- Experience performing laboratory testing, 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.