Job Title: Product Surveillance Analyst
Location: Minnesota (MN)
Duration: 6 months
Job Summary:
The Product Surveillance Analyst is responsible for managing product complaint investigations, evaluating returned medical products, documenting findings, and ensuring accurate complaint database entries. The role supports regulatory compliance, product performance analysis, audits, and cross-functional communication within a medical device/healthcare environment.
Key Responsibilities:
Initiate, manage, and maintain product experience/complaint files.
Investigate product complaints and returned products in a timely manner.
Record observations, photographs, testing results, and product condition details.
Enter and update complaint information accurately in the complaint database.
Evaluate returned products, including products used in surgical/biohazard environments.
Interpret product specifications, Device History Records, and measurement data.
Determine if complaints require escalation or medical device reporting to regulatory agencies.
Prepare technical reports, analysis summaries, and complaint trending charts.
Coordinate testing and investigations with Quality, R&D, Medical Affairs, Legal, and external consultants.
Support FDA, TUV, BSI, and other regulatory audits/inspections.
Follow QMS, EMS, FDA regulations, company policies, and safe biohazard/chemical handling practices.
Skills Required:
4-year degree in Science, Biology, Chemistry, Life Sciences, or related field.
Strong complaint handling and investigation skills.
Product performance or medical device investigation experience preferred.
Excellent documentation and database entry accuracy.
Strong analytical and technical reporting skills.
Highly organized with the ability to prioritize multiple tasks.
Strong written and verbal communication skills.
Cross-functional collaboration skills.
Ability to interpret technical specifications and quality records.
Knowledge of FDA/regulatory requirements preferred.
Comfortable working 100% onsite and handling returned surgical/biohazard products safely.

Product Surveillance Analyst

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