19 days old

Quality Systems Engineer II

Elkton, MD
  • Job Code
JobId: 378478
JobTitle: Quality Systems Engineer II
Department: Corporate_Compliance
Location: Elkton
Description: Job Summary:
The Quality Systems Engineer II is primarily responsible for developing, engineering, executing and maintaining the quality system and processes at Terumo Medical Corporation (TMC) in accordance with FDA and ISO quality systems and regulatory requirements. They will be required to utilize statistical thinking and methodologies to identify opportunities, plan improvements, execute those plans, and then follow up to ensure a proactive state of compliance. The position will be viewed and positioned as an in-house consultant to all departments required to facilitate quality systems and regulatory compliance. They will also support the maintenance and development of the TMC Corrective Action\/Preventative Action (CAPA) process. The successful candidate will be responsible for implementing a system that facilitates, develops and monitors both corrective and preventive actions. The support, maintenance and continuous improvement of the CAPA process is a primary responsibility. The Quality Systems Engineer II will serve as a CAPA Subject Matter Expert (SME). The individual will work on complex investigations and will coordinate technical teams to ensure sound experimental design, effective data analysis, identification, implementation, verification and validation of CAPA actions. We need the successful candidate to lead and continuously improve the CAPA Review Board (CRB). The successful candidate will provide training regarding CAPA and other quality systems to representatives from other functional areas. The Quality Systems Engineer II will monitor, analyze, and report Quality Management System metrics to Senior Management and key clients. As a minimum, this requires support of Management Reviews, Quality Systems Scorecards and Dashboards. The successful candidate will support and participate in cross-functional projects when assigned, facilitate technical innovations to support business goals and assist with other Quality System activities as requested by management. The Quality Systems Engineer II will lead high impact improvement projects within the business and assume the trainer\/mentor role for engineers and support personnel. In summary, the Quality Systems Engineer II must support the development of a quality\/business culture based upon effective compliance and continuous business improvement throughout TMC.

Job Details:
1. Develop, support, maintain and continuously improve the TMC Quality System in accordance with quality systems and regulatory requirements; especially requirements specified in the 21 CFR, Part 820, EN ISO 13485 and the Medical Device Directive.
2. Ability to develop, support, maintain and continuously improve policies, processes and procedures required to facilitate compliance and business efficiency.
3. Demonstrated ability to interpret and provide guidance on applicable and upcoming federal and international regulations; especially ISO 13485:2016, the Medical Device Regulations (MDR) and ISO 14971.
4. Ability to apply process analysis\/development tools to develop and continuously improve procedures required to maintain compliance and business efficiency (Ex. Fishbone diagrams, flowcharts, RACI, statistical applications).
5. Ability to maintain, develop and improve metrics required to establish the overall suitability and effectiveness of the TMC Quality System.
6. Ability to analyze\/evaluate business goals and identify improvement opportunities through the application of scientific methods, statistics and problem solving techniques.
7. Develop and implement processes for validating the effectiveness of quality systems processes. Research and evaluate regulatory trends to insure the compliant systems
8. Develop and implement a process for incorporating risk management into process development, maintenance and continuous improvement.
9. Plan and execute projects and team activities to facilitate changes that have a statistical impact on business results, especially as it relates to meeting and exceeding customer expectations.
10. Support the development, administration and continuous improvement of the TMC Corrective Action\/Preventive Action (CAPA) process. Develop and maintain metics and status reports that provide a status of the CAPA process and approved CAPAÙs.
11. Manage and continuously improve the TMC CAPA Board.
12. Provide active support for internal, third party and customer audits. This requirement includes the post audit requirements for reviewing, dispositioning, mitigating and incorporating any observations, nonconformances, opportunities for improvement and potential gaps\/preventive actions.
13. Develop, administer and continuously improve the training required to support the effectiveness and suitability of the quality system. This requirement includes the development, implementation and maintenance of specific Instructor Led Training (ILT) courses as cGMP Compliance, Good Documentation Practices and Process Development. 14. Provide practical, useful and effective quality systems reports for senior management, management reviews, business strategic initiatives and specific requests.
15. Provide leadership and support for global quality systems initiatives.
16. Support the development of a proactive and preventive quality systems culture throughout the business.
17. Complete other responsibilities as assigned.


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Quality Systems Engineer II

Elkton, MD

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Elkton, MD

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