Quality Systems Manager – Warsaw, IN

  • Lead the support for further development of the Company. QMS compliant to ISO 13485: 2016, FDA 21 CFR 820, and all other applicable medical device regulations, and also aligned with the Company QMS

  • Update and write SOPs and procedures in further development of the Company QMS

  • Assure compliance of processes with 21 CFR 820 Quality System Regulation and ISO 13485:2016

  • Ensure critical business and QMS processes are established, implemented and maintained

  • Support the further Implementation and management of Quality System version and document control

  • Support document retention and archiving systems

  • Conduct and coordinate annual internal audits as per predetermined schedule or as required

  • Establish and maintain procedures for process qualification and validation

  • Establish and maintain procedures to control nonconforming products and to prevent mix-ups

  • With department managers, plan and monitor business critical documentation review schedules

  • With department managers, identify and implement internal controls required for business-critical processes

  • Identify gaps or non-conformance in business-critical process and work with management to resolve in line with best business practices

  • Review and identify continual improvements as required within the quality manual and policies and procedures necessary to the quality system

  • Prepare and present report to summarize the result of internal audits, CAPA/NCR and any opportunities for improvement to management team for review

  • Report to Vice President of QA/RA on performance of the Quality Management System

  • Work with Customer Service and Logistics at Company with respect to import requirements of the FDA in order to enhance procedures for facilitating importation of products       

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