About The Position

The Sr. Specialist, Product Training Compliance role supports the Structural Heart (SH) Global Training and Education team by defining technical and operational requirements that drive training processes and the Learning Management System (Mentor) for field teams, physicians, and healthcare professionals (HCPs). This position works in the Structural Heart division. The business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. This is a remote role.

Requirements

  • Bachelor’s Degree (BA/BS) or Equivalent
  • Strong interpersonal and communication skills
  • Excellent planning and organizational skills.
  • Proficiency in multiple computer-based tools and software programs such as Word, PowerPoint, Excel, Visio, MS Project, SharePoint.
  • Experience working with Microsoft Power Platform Tools such as Power Apps, Power Automate, Forms, and Power BI.
  • Experience with Medical Device Learning Management System(s).
  • Knowledge of quality system regulations and the application of regulations within quality systems.
  • Experience working with IT systems development projects.
  • Experience working in global teams.
  • Proven ability to lead and manage quality improvement projects.
  • Experience in business process development and improvement and reporting strategies.
  • CAPA work experience in Product Training environment.

Responsibilities

  • Developing, implementing, and maintaining quality management systems to ensure compliance with industry standards and regulatory requirements.
  • Supporting continuous improvement initiatives, conducting audits, and collaborating with cross-functional teams to drive continuous improvement in product and process quality.
  • Developing global technical strategies and solutions through cross-functional collaboration, ensuring compliance with quality standards, and building efficient, repeatable processes to maintain quality across SH product lines.
  • Assisting in the development and execution of technical strategies to manage training records through Mentor.
  • Supporting the implementation of technology solutions to automate business processes, enhance compliance, and optimize training infrastructure.
  • Integrating compliant quality systems and training records management within Mentor and other interdependent technologies.
  • Developing solutions that ensure compliance while balancing technology use and resource management.
  • Adhering to all relevant quality policies and procedures to maintain high standards.
  • Collaborating with global stakeholders across the US, EMEA, APAC, and CALA to identify technical needs and implement process solutions.
  • Leading or supporting cross-functional teams and projects focused on technical solutions for training compliance.
  • Working closely with stakeholders to align on training infrastructure solutions and develop shared understanding.
  • Fostering a high-performance culture with strong accountability through collaboration and engagement.
  • Ensuring alignment with corporate and divisional policies and maintaining compliance with global quality system requirements.
  • Analyzing quality data and metrics to identify trends and areas for improvement.
  • Preparing and presenting quality reports to management and stakeholders.
  • Supporting the development of strategies for training infrastructure and ensuring compliance with data management policies.
  • Coordinating/facilitating meetings and/or communicating cross-functionally to develop solid solutions to CAPA activities.
  • Managing CAPA projects and tasks.
  • Providing concise updates to stakeholders and leadership on technical solutions and project progress.
  • Developing reporting tools and systems to enhance visibility and management of training activities.
  • Managing interdependencies and change management across SH product lines and functions.
  • Acting as a subject matter expert for business process and technical solutions supporting the training infrastructure.
  • Ensuring timely and effective resolution of customer complaints and non-conformances.
  • Building and maintaining strong relationships with internal teams and external partners at all levels of the organization.

Benefits

  • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • An excellent retirement savings plan with a high employer contribution.
  • Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
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