Quality Engineer - Post-Market Surveillance

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.

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