Ruth Hansen Email & Phone Number

• Responsible for the establishment and maintenance of the Quality System Audit program.• Audit and evaluate the compliance of the Quality System to applicable standards and regulations such as FDA Quality System Regulation, ISO 13485:2003, ISO 13485:2012, ISO 13485:2016 , MDSAP, Canadian Medical Device Regulation and the Medical Devices Directive.• Created and Managed project for the 13485:2016 and MDSAP certification • Actively participate and lead/facilitate continuous improvement of the Quality System with a focus on customer satisfaction, internal performance metrics and internal audits that focus beyond compliance.• Ensure, through process-based internal audits• Establish, lead, train and manage internal audit team.• Develop, evaluate and maintain metrics to assess the ongoing performance of the Quality System.• Evaluate and lead implementation of new and/or revised standards and regulations applicable to Medical Device Quality Systems.• Act as the key contact for product certification agencies (BSI, TUV, UL, CSA, etc.).• Manage CAPA system. Ensure corrective and preventive actions are implemented, monitored and evaluated for effectiveness. Lead and facilitate 3rd party audits.• Respond to outside customer requests and surveys.• Participate by providing input and post market information on Risk Management Activities

• Senior Quality System Auditor

  Sh Compliance & Service Consulting

  Saint Paul, Mn, Us

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  Century College - Company

  3.5