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.
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 (SOP's). 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.
Knowledge, Skills and Abilities
Requires at least 5 years work experience in Quality/Compliance within a regulated industry.
Significant work experience in Quality System Auditing (ASQ certification or ISO Lead Audit certification is required).
Knowledge of national and international regulations applicable to medical devices including: FDA 21CFR Part 820(QSR), ISO 13485, SOR 98-282 CMDR (Canada Medical Device Regulations, MDD (European) requirements, etc.
Apply effective time management, critical thinking, problem solving and collaborative approaches to improving internal audit program
Excellent communication skills and the ability to express ideas both orally and in written form.
Well organized and accustomed to maintaining excellent records
Ability to work with team members across functions/departments.
Ability to effectively present information to top management and team members.
Ability to identify priorities and function independently required.
Ability to analyze situations thoroughly, identify potential problems, find and implement effective solutions .
BS in Science or Engineering. Equivalent QA experience considered.
Computer skills including: Word, Excel, PowerPoint and management of spreadsheets and generating reports
Certified Quality Auditor (CQA) certification required and/or ISO 13485 lead auditor certification
Experienced lead auditor for medical device industry
Demonstrated understanding of industry regulations, including detailed knowledge of FDA QMS and ISO 13485