Medical Device Product Quality Engineer
8 Month Contract
Identify, analyze, investigate, monitor and document patterns and trends in post marketing surveillance data as part of the CAPA system. Analyze and investigate product complaints from the field as part of post market surveillance requirements. Communicate and educate management, R&D, marketing, sales organization and other departments, as well as external customers about product performance. Ensure that information and insight gained from the investigations and corrective actions is fed back to the R&D and marketing organizations as part of the risk management and design input systems. Develop Post Market Surveillance Plans and provide engineering support for complaint investigation readiness of new products.
1. Analyzes customer complaints, events and other post marketing surveillance data by examining the data for patterns and trends and investigating when necessary
2. Investigates customer complaints related to product quality or patient safety
3. Investigates identified trends by starting a formal trend investigation and trend report and working on cross-functional teams
4. Documents trend action by updating the trend report at appropriate levels and by performing a Health Risk analysis
5. Communicates product performance by formal presentations to management committees and design teams, supporting published product performance reports and supporting customer requests for performance information either directly or through the sales organization
6. Develop test plans, procedures, justifications papers and provide engineering support for new product complaint readiness.
Required Education & Experience
Bachelor's degree plus 2-5 years of related work experience with a good understanding of specified functional area, or Master's degree with 0-2 years of related work experience.