Analysis Skills, Biology, Biomedical Engineering, Biotech and Pharmaceutical, Chemistry, Communication Skills, Consulting, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, External Audit, FDA (Food and Drug Administration), FDA Requirements, Internal Audit, Medical Equipment, Organizational Skills, Product Documentation, Product Support, Product Testing, Quality Assurance, Record Keeping, Regulations, Regulatory Compliance, Regulatory Reports, Reporting Skills, Research & Development (R&D), Safety Process, Surveillance, Trend Analysis
Hiring: Analyst, Product Surveillance
Location: St. Paul, Minnesota
Duration: 6 Months Contract (Contract-to-Hire Opportunity)
Type: W2 Contract
Industry: Medical Devices
We are actively hiring an Analyst, Product Surveillance for a leading Medical Device company. This role is ideal for candidates with experience in medical device complaint handling, product investigations, and regulatory compliance. You'll investigate customer complaints, evaluate returned products, and support quality and regulatory activities.
Key Responsibilities:
Investigate product complaints and returned medical devices
Perform product evaluations and document investigation findings
Maintain complaint records and complaint database
Support FDA/MDR reporting and regulatory compliance
Coordinate testing with Quality, R&D, and cross-functional teams
Prepare technical reports and complaint trending analysis
Follow QMS procedures and safe biohazard handling practices
Support internal/external audits and quality initiatives
Requirements:
Bachelor's degree in Biology, Chemistry, Life Sciences, Biotechnology, Biomedical Engineering, or related field
2 5 years of experience in medical device complaint handling, product investigations, quality, or product surveillance preferred
Knowledge of FDA regulations, MDR, QMS, and CAPA
Strong analytical, organizational, and communication skills
Experience with complaint databases, returned product analysis, or product performance investigations is preferred