Role: Quality Engineer - Post-Market Surveillance
Location: Louisville, CO, 80027
Emp Type: Permanent Job
Interview: Phone/Skype
2-3 years in Post-market Surveillance in Medical Device Industry
Must have skills*
• Knowledge and understanding of FDA or EU MDR requirements of Post-market Surveillance planning & reporting for medical devices
• Experience in preparing Post-market surveillance plans & reports including compilation & analysis of Post market surveillance data on devices
• Knowledge and understanding of Quality system requirements and applicable standards for Medical devices (e.g., ISO13485, FDA 21CFR820, ISO 14971)
• Working knowledge of risk management tools (Risk Analysis, FMEA, FTA etc.)
• Ability to interface with the end client and represent and its suite of capabilities
• Excellent verbal and written communication skills
Good to have skills*
Candidates having experience with Image Guided Navigation systems & associated instrumentation, Catheters, Shunts, Ports will be preferred.
3-6 years in Quality Engineering, preferably in MedTech industry
• Prepare Post-market surveillance plans & reports including compilation & analysis of Post market surveillance data on devices
• Update risk management files and completion of risk management reports
• Review and update Standard Operating Procedure (SOP), Work Instruction
• Compile and analyzing and trending of data (in particular complaint data)
• Support to comply with EU MDR requirements in the area of Post Market Quality and Risk Management
• Participate in the project core team meetings, discuss the requirements and take inputs, information from the cross functional team members to complete the project deliverables
• Change management for approval and release of final PMS plans & reports
• The PMS Quality Engineer is responsible for all EU MDR- PMS projects out of the concerned division of the customer organization.Coordinate with multiple functions like Development, Manufacturing, Product Quality, Regulatory, and Doc control for approval & release of project deliverables in a timely manner. Communicate project status to management on a regular basis and escalate if necessary.
Bachelor of Engineering in Mechanical, Electrical, Industrial or related field
Quality Engineer,PMS Engineer,Post-market Surveillance, Post Market Monitoring, Medical Device, Field Actions, Risk Management, EU MDR, ISO 13485
The job profile requires working with cross-functional team to ensure compliance to the client’s Quality policy & procedures aligned with EUMDR and other applicable regulations like ISO 13485, ISO 14971. In this role, Consultant will mainly sustain existing product lines by preparing PMS plan & PMS reports and supporting risk management document review & update to comply with MDR requirements.