Job Description: This position supports a wide array of activities related to: NCR/CAPA, Change Control, Product Surveillance, Design Control, New Markets and Risk Management.
NCRs and CAPAs including: capturing data and investigations associated with product deviations, product nonconformance's, CAPAs, scrap, and rework, and analyzing the data for the reasons of Quality Improvement and reporting.
Support Change Control activities - Originate and review internal operating procedures and specifications through the Document Change process.
Adherence to regulations - Assist with adherence to all Federal, State, and Local Regulations controlling the manufacture of medical devices.
Support the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards.
Execute Investigations, Root Cause Analysis, Correction, Corrective and Preventive Action activities in accordance with the Quality System Corrective/Preventive actions and product non-conformance control including: capturing data and investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.
Originate, review, and approve internal operating procedures and specifications through the Document Change process
Support Product Surveillance through review and ownership of data/trend evaluations and investigations associated with product and patient complaints, analyzing the data for the reasons of Quality Improvement and reporting.
Support New Markets activities including: management of new markets samples process, coordination between new markets group in Germany and WI Tech Ops to manufacture samples, filing of applicable new markets documentation in the Design History File (DHF)
Support Risk Management activities including: data preparation for annual product risk file review, review internal documents (IFU, CER, etc.) for annual product risk file review, management and preparation of event-based reviews, review and coordination of quality activities related to pFMEA risk matrices.
BS/BA in Physical Science or Engineering.
Fresh grads encouraged to apply.
Experience in Quality Assurance and/or other regulated industry or similar experience a plus.
Strong technical writing skills and general problem solving skills.
Manage multiple priorities and work with interruptions.
GLP and/or GMP experience a plus.
Medical Device knowledge a plus.
Requires Vision Assessment (20/20 near visual acuity & acceptable color vision).