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Senior Quality System Specialist
hace 2 meses
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.
Key Responsibilities- Main attendee to Magellan SO workstream and cross-functional meetings to determine impact in specific topics or actions.
- Work with local Country Quality teams to identify specific local requirements.
- Coordinate cross-functional activities.
- Provide Quality oversight, analyzing Regional and Global impact on cross-functional decisions.
- Collaborate 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.
- Conduct demo analysis with Subject Matter Experts (SME) within the region, documenting and following up on 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.
- 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.
- 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.
- Good understanding and knowledge of ISO 13485 and associated Quality system requirements for the EMEA region focused specifically on Distribution channels (for example, Distribution Centers, Third-Party logistics suppliers, Field inventory Programs, and Distributors) to effectively represent EMEA Quality in different workstreams on Magellan cross-functional meetings.
The successful candidate should ideally be located close to an EMEA Boston Scientific Hub/Office and be willing to travel as needed within the Region, particularly to provide support and attend meetings during critical project deployment phases. You can work hybrid (2-3 days at the office) and we will start with a defined-term contract of 18 months.
