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Quality Engineer QMS Transformation

Sunrise, Florida
8 Sep 2022

TPosition Summary

Provide leadership to the QMS Transformation staff to support global projects, change initiatives and oversee aspects of the QMS Transformation Program. Drives standardization and simplification improvements for QMS processes, procedures and practices. Works in partnership with other Terumo Group Affiliates and Program Managers to assess and implement best practices across the organization to continuously meet regulatory and customer requirements. This role will have significant visibility across the organization and will enable to organization to operate on a simplified, standardized Quality Management System across our company.

Key Accountabilities:

Work within the established procedures and Terumo Aortic's Quality Management System requirements and Terumo Core Values at all times

Conduct gap assessments within the QMS documentation, and recommends action items following a risk-based approach

Advise key stakeholders and core team members on the application of best practices and effective compliance to internal and external regulations and standards

Gather relevant information from various sources and reports periodically to Terumo Corporate Quality Assurance Department (QAD) / QCO Staff monthly quality site date as well as the status of open action items and corporate initiatives.

Conducts Root Cause Analysis and implement Corrective Actions to address Quality and/or compliance issues under various quality systems such as Non-conforming Reports (NCRs), CAPAs, Audits.

Supports external audits as SME for Global QMS processes, procedures, and records

Keeps management and relevant teams informed on industry regulatory trends, changes and best practices

Participates in the development of global policies and procedures in support of the QMS and following the established program timelines

Able to influence change and decisions to meet desired organizational objectives and results

Develop training materials and train personnel on new/revised QMS processes and practices

Establish Key Performance Indicators for QMS Compliance and reports periodically

Internal Networking/Key relationships

This position requires cooperating with different departments across the global organization, such as Quality, IT, Engineering, R&D, Regulatory, Operations, Finance, and HR.

Minimum Skills and Capabilities:

Effective leadership skills within a geographically and culturally diverse organization

Excellent Written and Verbal Communication

Ability to interact with all levels within organization

Document and Change Control Experience

Excellent written and verbal communication skills in English

Direct experience using eQMS software (e.g. MasterControl, TrackWise, EtQ)

Minimum Knowledge & Experience required for the position:

Bachelor's degree in a Life Sciences, Engineering, or relevant discipline.

3 + years of leadership experience within regulated industry and relevant experience in quality assurance and/or regulatory affairs roles.

2 + years of direct work experience with Quality Management Systems administration

Experience working within a global environment and remote teams

Thorough understanding of Medical Device Quality Management System (QMS) Regulations and Standards (e.g. 21CFR820, EU MDR, ISO 13485)

Certified Quality Engineer (CQE) or Auditing certification a plus

Experience working within a Global Corporate environment a plus

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  • Job Reference: 706736102-2
  • Date Posted: 8 September 2022
  • Recruiter: Terumo Medical Corporation
  • Location: Sunrise, Florida
  • Salary: On Application