Boston Scientific Senior Quality System Specialist 

United Kingdom, England, Dacorum 

70768771

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

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.