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Responsibilities: include, but are not limited to the following:

·       Review the management of CAPA (Including follow-up and assurance that the objective evidence of efficacy is captured)

·       Review and management of the customer feedback and complaint process

·       Review and management of the Risk Management Process

·       Review and assess manufacturing procedures

·       Identify Quality Issues

·       Execution of Internal Audits

·       Execution of Functional Testing

·       Maintain Awareness of regulatory changes and notify appropriate personnel of make necessary changes to maintain compliance

·       Develop and distribute professional and formal response to customer-reported quality problems

·       Seek and exploit opportunities to improve the QMS

·       Maintains current knowledge of government and industry compliance standards

·       Provides expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance

·       Technical writer

·       Develops and maintains auditing schedules.

·       Performs other duties as assigned by the Quality Manger

·       Communicates between customer and Senior management

 

 

Job Qualifications/Requirements:

·       Bachelor's degree (B.S.) in related field or equivalent preferred

·       Four to six years related experience or equivalent preferred

·       Strong knowledge of manufacturing processes, computer and equipment validation, GMPs, and product/process validation,
ISO 9001 , ISO 13485:2016 and 21 CFR Part 820

·       Knowledge and experience with REACH, RoHS, ECHA, & UKCA

·       Knowledge and experience with UDI labeling

·       Knowledge and experience in Statistical in evaluation and analysis of data.

·       QC Inspection Techniques