Senior Quality System Specialist
il y a 1 semaine
The Senior Quality System Specialist will play a key role in the EMEA Magellan program, working closely with the EMEA Magellan Distribution Quality Lead and EMEA Quality Core team to assess and evaluate the implementation impact on EMEA Satellite Offices. This role will serve as a key connection among cross-functional stakeholders at country level, Quality superusers, and EMEA Magellan Distribution Quality lead.
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.
- Coordinates cross-functional activities.
- Provides Quality oversight, analyzing Regional and Global impact on cross-functional decisions.
- Collaborates with other EMEA Core team functional leads, supporting the EMEA Magellan Quality Distribution Lead to make an alignment on EMEA Quality assurance (Operations) processes.
- Supports the team in assessing Magellan impact on active projects.
- Evaluates new end-to-end processes and impact of those on Regional and Global requirements.
- Works with local teams to identify and mitigate program risks and impacts at site level.
- Demonstrates analysis with Subject Matter Experts (SME) within the region, documenting and following up on detailed questions raised during demo sessions.
- Tracks deployment activities and escalates risks as needed.
- Supports local document updates for changes coming from Magellan.
- Supports main processes impacted by Magellan, namely Production and Process Controls and Field action as key processes impacted by Magellan in EMEA.
- Bachelor's degree.
- Experience working in the medical device 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 of ISO 13485 and associated Quality system requirements for the EMEA region, focused specifically on Distribution channels.
Boston Scientific is a leader in medical science for over 40 years, committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
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