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Boston Scientific Senior Quality System Specialist 
Spain, Community of Madrid, Madrid 
688311796

09.08.2024

Spain-Madrid; France-Voisins le Bretonneux; Germany-Düsseldorf; Italy-Milan; Netherlands-Kerkrade

About the role:

Key to their success will be their ability to develop, establish and maintain quality processes which meet Boston Scientific, customer, and regulatory requirements.

Your responsibilities will include:

  • Main attendee to Magellan SO workstream and cross functional meetings to determine impact in a specific topic or action.
  • Works with local in Country Quality teams to identify specific local requirements.
  • Coordinate cross functional activities.
  • Provide Quality oversight, analyzing Regional and Global impact on cross functional decisions.
  • Collaboration with other EMEA Core team functional leads, supporting the EMEA Magellan Quality Distribution Lead to make an alignment on EMEA Quality assurance (Operations) processes.
  • Supporting team in assessing Magellan impact on active projects.
  • Evaluating new end-to-end processes and impact of those on Regional and Global requirements.
  • Work with local team to identify and mitigate program risks and impacts at site level.
  • Demo analysis with Subject Matter Experts (SME) within the region. To document and follow up detailed questions raised during demo sessions.
  • Track deployment activities and escalate risks as needed.
  • Support local document updates for the changes coming from Magellan.
  • Support main processes impacted by Magellan, namely Production and Process Controls and Field action as key processes impacted by Magellan in EMEA.

Who we are looking for:

  • Bachelor’s degree
  • Experience working in medical device (or related) industry required.
  • 5-7 Years of experience; relevant functional experience within the areas of distribution channels
  • Functional knowledge on SAP
  • Demonstrated capability in collaborating and partnering within a global environment / matrix organization.
  • Experience with managing distribution/warehousing activities.
  • Experience working in cross-functional teams and driving projects to completion.
  • Proven track record in building a continuous improvement culture based on business excellence principles and methodologies.
  • Ability to work independently and as a member of a team in a dynamic environment.
  • Strong interpersonal communication, collaboration and influencing skills.
  • Strong decision-making skills, focus prioritization linked to risk management, problem solving and time management skills.
  • High sense of urgency and commitment to execution in a fast-paced environment
  • Project Management skills (Agile, flexible, dynamic)
  • Good understanding and knowledge on ISO 13485 and associated Quality system requirements for EMEA region focused specifically on Distribution channels (for example Distribution Centers, Third-Party logistics suppliers, Field inventory Programs, and Distributors) to be able to effectively represent EMEA Quality in different workstreams on Magellan cross-functional meetings.