Quality Engineer Cincinnati, Ohio - United States | Posted - 04/09/19 Overview
5+ Years in Medical Device Industry
Understanding on Medical Device Quality
Know how on ISO 13485
Experience Complaints Handling
Knowledge on Medical Device Regulatory Standards
Able to adapt to changing/emerging data requests from a variety of different system applications
Experience in Medical Device Industry
Experience in Complaint Management
Experience in Post-Market-Surveillance of Medical Device
Roles & Responsibilities
Own the collection, creation, and presentation of periodic reports & presentations related to product risk escalations and field action processes for both the CSS and Ethicon business platforms.
Develop strategies and capabilities to harmonize metrics and data reporting among different operating companies.
Support the investigation and documentation of product risk assessments and Field Action activities when needed.
Support process improvement activities related to the product risk escalation and field action processes.
Generic Managerial Skills
Make decisions on selection of suitable manufacturing process based on the project needs in concurrence with the customer
Meet delivery promise in terms of budget and timescales
Track Project progress and make necessary changes to project execution as needed to ensure achievement of project goals
Work within a multi-discipline team, consisting of the R&D Development Group, Marketing, Quality, Operations
Liaison with customer designated point of contact and functional area point of contact
Multiple Project Planning and execution
A Bachelors Degree in Mechanical Engineering or in relevant field is required. An Advanced Degree in a related field is an asset
Associated topics: aerodynamic, autocad, bsme, mechanical, msme, propulsion, rotordynamic, thermal, vehicle, vibration
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.