About the role: The Senior Quality System Specialist will serve as a key Regional Quality Functional Representative on the Magellan Program for EMEA Satellite Offices (SO), working closely with the EMEA Magellan Distribution Quality Lead and EMEA Quality Core team to assess and evaluate the Magellan implementation impact locally on the EMEA Satellite offices in the region.
This key role in the EMEA Magellan program will act as a connection among cross-functional stakeholders at the country level, Quality superusers, and the EMEA Magellan Distribution Quality lead.
This role will participate in SO workstream and cross-functional meetings, providing Quality oversight by analyzing Country/Regional impact of cross-functional decisions related to Satellite Offices.
This role will support onsite implementation of new Satellite Offices processes under Quality and cross-functional perspectives (i.e., training in new processes, procedures updates, Change impact assessment).
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 on specific topics or actions.
Work 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 align on EMEA Quality assurance (Operations) processes.
Support the team in assessing Magellan impact on active projects.
Evaluate new end-to-end processes and their impact on Regional and Global requirements.
Work with local teams to identify and mitigate program risks and impacts at the site level.
Demo analysis with Subject Matter Experts (SME) within the region.
Document and follow up on detailed questions raised during demo sessions.
Track deployment activities and escalate risks as needed.
Support local document updates for 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 the medical device (or related) industry required.
5-7 years of experience; relevant functional experience within the areas of distribution channels.
Functional knowledge of 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.
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