Senior Quality System Specialist

hace 3 meses

Madrid, España Boston Scientific A tiempo completo

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 that 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 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 site level.

Demo analysis with Subject Matter Experts (SME) within the region to 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.

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 (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 (London, Paris, Madrid, Milan, Kerkrade, Warsaw) 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.

Requisition ID : 588491

As a leader in medical science for more than 40 years, we are 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.

Now more than ever, we have a responsibility to apply those values to everything we do as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you

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