2 days old

Senior Quality Compliance Auditor

Elkton, MD
  • Job Code
JobId: 379945
JobTitle: Senior Quality Compliance Auditor
Department: Corporate_Compliance
Location: Elkton
Description: Job Summary:
This position is responsible for assisting with the implementation of best practices to optimize quality, efficiency & productivity in systems throughout TMC and other Terumo facilities. This position is responsible for the execution of Internal Audit activities and administration of the Internal Audit process in accordance with Company procedures. This position will interface with individuals at all levels of the organization to conduct audits at specified intervals and report audit findings, facilitate and monitor the life-cycle of audit findings until completion, promote continuous improvement of systems, products, and services, establish and maintain QMS systems that are in conformance with international and local requirements, manage and support the global external regulatory compliance inspections, responses, and action implementation follow up, support internal audits by acting as an auditor or driving completion of audit actions when required and analyze and monitor quality data to identify potential high risks and implement necessary actions to mitigate compliance and product risk. This position will provide guidance to assist in the development, implementation, and maintenance of the Quality Management Systems to ensure the organization functions effectively and efficiently in order to ensure a high level of Regulatory Compliance and to achieve Company goals, objectives, and policies as well as satisfy customer requirements.

Job Details:
1. Provide support for the Business internal and external audit compliance strategies. 2. Implement changes to the Quality System procedures\/forms as needed to maintain compliance, improve effectiveness and efficiency. 3. Administer the Internal Audit Program. 4. Interface with FDA and third-party auditors during inspections. 5. Monitor and remain current with internal company procedures\/policies, International QS standards and federal regulations. 6. Assist the Management with tasks such as FDA correspondence. 7. Participate in the validation and implementation of Quality System Software. 8. Leads\/Assists quality system audits to ensure the QMS operates in a state of compliance and continuous improvement. 9. Prepare audit reports and conduct audit briefings upon completion of audits. 10. Document audit reports within specified time frames and generate audit corrective action requests as applicable. 11. Follow, interpret and develop written Policies and Standard Operating Procedures (SOPÙs). 12. Monitor internal audit non-conformances, perform trend analyses, and present findings. 13. Contribute to the development and improvement of audit program metrics. 14. Participate in process improvement activities to continuously improve process effectiveness. 15. Other activities as assigned by QA management.


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Elkton, MD

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Elkton, MD

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