Quality Engineer

Location

Blue Ash, OH | United States

Job description

Quality Engineer5+ years of work experience in the Medical Device industry in Quality role Understanding on Medical Device Quality and Compliance Knowledge on ISO 13485: 2019 and 21 CR 820 Experience in Complaints Handling, Post Market Surveillance Knowledge on Medical Device Regulatory Standards, MDD and MDR Knowledge on NC, CAPA, Audit processes Medical Devices Risk Management. Can also identify less obvious risks in a given business opportunity. Experience with Application, Process, Design and System FMEA etc. Able to adapt to changing/emerging data requests from a variety of different system applications. Experience with statistical tools and techniques including DOE. Able to perform advanced descriptive and non-parametric statistical analyses. Can translate stressors into an executable test that accurately predicts field reliability; able to use advanced statistics for prediction Experience in Medical Device Industry Quality and Compliance Experience in interpretation of regulations, standards and performing impact assessment on Quality system documents. Ownership to close CAPA, driving risk management activities. Experience in Post-Market-Surveillance, Complaint Management of Medical Device Experience with ISO 14971 requirements, and can guide team to apply risk management system; knowledge of interconnections of FMEAs; can make decisions based on FMEA output

Provide technical support on organization's quality processes within QMS. Work with cross functional teams and internal teams to create deliverables. Interpret new/ upcoming quality/ regulatory requirements and provide guidance 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 Take complete ownership of the quality aspects of the project including managing other quality associates working in the project. Knows whether to outsource based on capacity, criticality, and complexity of the activity. Take a well thought out and planned approach involving multiple arguments or steps. Anticipates the interests, reactions, or objections of others and adapts a multi-part influence strategyA Bachelor's Degree in Mechanical Engineering or in a relevant field is required. An Advanced Degree in a related field is an asset.

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