Senior Quality System Specialist

Boston Scientific; Madrid; Presencial; EUR 45.000 - 80.000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Senior Quality System Specialist to join their dynamic team. This pivotal role involves collaborating with cross-functional stakeholders to ensure quality oversight and compliance within the EMEA Magellan program. The successful candidate will leverage their extensive experience in the medical device industry to assess and implement quality processes, while also supporting the training and development of new procedures. With a commitment to excellence and a focus on continuous improvement, this role offers a unique opportunity to make a significant impact in a fast-paced environment. If you are a proactive problem-solver passionate about enhancing quality standards, this position is the perfect fit for you.

Formación

• 5-7 years experience in the medical device industry required.
• Strong knowledge of ISO 13485 and Quality system requirements.

Responsabilidades

• Provide Quality oversight and analyze Regional impact of decisions.
• Support onsite implementation of new processes and training.
• Coordinate cross-functional activities and evaluate new processes.

Conocimientos

Medical Device Industry Experience

SAP Functional Knowledge

Collaboration Skills

Project Management

Interpersonal Communication

Decision-Making Skills

Risk Management

Problem-Solving Skills

ISO 13485 Knowledge

Continuous Improvement Culture

Educación

Bachelor's Degree in a Relevant Field

Herramientas

SAP

Descripción del empleo

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 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 from a 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 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 in a specific topic or action.
• 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 the 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:

• 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 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, focused 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 (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!