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Senior Quality System Specialist
Il y a 2 mois
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, 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 key connection among cross-functional stakeholders at country level, Quality superusers, EMEA Magellan Distribution Quality lead. This role will participate in SO workstream and cross-functional meetings, will provide 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 perspective (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.
Responsibilities:
- 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.
Requirements:
- 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.
