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.

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