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Principal Quality Systems Engineer

Company: Terumo Medical Corporation
Location: Somerset
Posted on: August 8, 2022

Job Description:

Job Summary: The Principal Quality Systems Engineer is responsible for providing quality system leadership and insight into the global quality system requirements to support the TMC business as it continues to grow and change. They will collaborate with key internal business and technical stakeholders to work cross functionally to improve the overall Terumo (TMC) Quality Management System and provide sound design approaches to navigate the Quality System requirements to ensure compliance in a logical and efficient manner. The Principal Quality System Engineer will be the Subject Matter Expert for TMC's electronic quality management system. Job Details:

  • Develop, design, maintain, and continuously improve the TMC Quality system in accordance with applicable regulations for a global medical device corporation.
  • Help to streamline the quality system for efficiency, effectiveness, and compliance.
  • Drive the deployment of the quality system to all Terumo Medical sites and subsidiaries.
  • Integrate standard quality system tools for managing the quality system.
  • Utilize process improvement and problem-solving methodologies to continuously improve the quality system.
  • As the quality system technical lead, support TMC sites and subsidiaries on compliance and quality system related challenges.
  • Apply root cause investigation and/or process development tools (ex: six sigma) to determine changes required.
  • Provide quality system expertise to guide teams in implementing robust solutions.
  • Work with site personnel to identify root cause and corrective action plans to improve the quality system.
  • Act as the subject matter expert for TMC's electronic quality management system (eQMS) and electronic document management system (eDMS)
  • Implement and maintain a complaint eQMS/eDMS for TMC & subsidiaries.
  • Drive implementation of new and improved workflows to support the growing business and/or revised requirements.
  • Work with all functional SMEs across all TMC sites & subsidiaries to ensure the system is effective and efficient.
  • Lead work with software vendor to ensure quality system requirements are met.
  • Generate metrics & dashboards to demonstrate the performance of the quality system.
  • Develop and provide training for eQMS/eDMS system as subject matter expert.
  • Oversee the TMC change management process in alignment with 21 CFR Part 820, ISO 13485, and other global medical device regulations. (EU MDR and multi country)
  • Manage the change management process including a portfolio of projects to ensure they are being managed in a timely and compliant way.
  • Review Change control plans and, as needed, provide guidance, coaching, and other leadership to help change owners and leaders develop optimized change control plans and documentation.
  • Lead and own the organization and management of the Change Management Board.
  • Support the development of a proactive and preventive quality systems culture throughout the business.
  • Mentor other quality professionals to support the organization in establishing a high performing team.
  • Lead assist and/or conduct internal audits to assess compliance with applicable regulations and standards (e.g. - Quality System Regulation (QSR), ISO 13485, ISO 14971, ISO 11607, ISO 11135/ EN550, ISO 11137/ EN552 and the Medical Device Regulation).
  • Assist with third party/regulatory audits (Customer, Notified Body, FDA)
  • Performs other job-related duties as assigned.
    Position Requirements: Knowledge, Skills and Abilities (KSAs)
    • Quality and business process knowledge:
    • Extensive experience with FDA, ISO 13485, EU MDR, and multi-country Quality Systems requirements.
    • Ability to navigate implementing products and processes in an efficient and compliant manner.
    • Demonstrated ability to use process development tools (ex. Lean Six Sigma)
    • Demonstrated ability to apply a practical level of statistics.
    • Ability to develop and maintain spreadsheets, pivot tables, metrics, statistical applications, charts/graphs, and user-friendly reports
    • Demonstrated ability to communicate and interact with all levels of the organization including Executive Leadership management
    • Strong interpersonal skills to provide coaching, training, and direction
    • Demonstrated ability to provide clear direction and mentor personnel.
    • Strong proofreading and writing skills, as well as exemplary attention to detail
    • Demonstrated organizational and prioritization skills
    • Exceptional decision-making including the ability to rapidly understand complex changes and pace work completion to the needs of the company.
    • Demonstrated initiative and ability to work independently while handling multiple tasks
    • Strong computer knowledge (MS Office), technical writing skills and proofreading ability
    • Demonstrated ability to work effectively with cross- functional teams for problem-solving, product and process improvement is required. Background Experience - B.S. degree or combination of equivalent education, background, and experience in Scientific or Engineering discipline required. - Advanced degree preferred. - Minimum 15 years' overall experience with at least 10 years of related experience in medical devices/diagnostics, pharmaceutical or other regulated industry required with a focus on quality system responsibilities. - Six Sigma certification preferred.

Keywords: Terumo Medical Corporation, Trenton , Principal Quality Systems Engineer, Other , Somerset, New Jersey

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