Quality Specialist II

Boston ScientificArden Hills, MN
412d

About The Position

The Quality Specialist II role at Boston Scientific focuses on enhancing quality awareness and communication regarding quality initiatives. The position primarily involves handling customer complaints, ensuring compliance with Good Manufacturing Practices (GMPs), and regulatory requirements. The specialist will analyze complaints, coordinate activities with various stakeholders, and support the development of quality systems and metrics to meet organizational and regulatory standards.

Requirements

  • Bachelor's degree and 1-3 years of work experience.
  • Complaint handling experience.
  • Ability to read, analyze and report data.
  • Excellent written and oral communication skills.
  • Strong sense of responsibility and attention to detail.
  • Ability to actively engage divisional and regional resources.
  • Ability to work with a virtual team.
  • Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, SharePoint).
  • Experience with Microsoft Dynamics 365, Help Desk Ticket System, Azure DevOps.
  • Experience as an NCEP/CAPA owner.
  • Understanding of quality management systems.
  • Understanding of data management/information management.
  • Project management experience.
  • Technical writing and editing skills.

Nice To Haves

  • 2-3 years of experience in a related field.
  • Previous Quality Assurance or complaint handling experience preferred.
  • Team player with excellent coordination, interpersonal and communication skills.
  • Self-directed requiring minimal supervision.
  • Understanding of the Boston Scientific Cardiac Diagnostics quality system.

Responsibilities

  • Support the development/enhancement of product data quality systems.
  • Support data management activities.
  • Support compliance analysis and metrics.
  • Participate in projects supporting Best 4 Quality.
  • Lead and/or participate on NCEP/CAPA teams.
  • Manage VIP projects.
  • Own and manage processes.
  • Develop and deliver communication and training.
  • Perform other duties as necessary or required by the department or organization.
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