Boston Scientific
Quality System Specialist - Field Action (FA) Process
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Quality System Specialist (Field Action Coordinator) – EMEA Region
Location: Hybrid (3 days on-site, 2 days remote) – United Kingdom (Hemel Hempstead), Italy (Milan), Spain (Madrid) Company: Boston Scientific
Our Promise: Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we empower you to grow personally and professionally by working in a team of diverse, high-performing individuals. With cutting-edge tools, knowledge, and continuous support, we foster progress toward your career goals—whatever your ambitions may be.
Role Overview
We are seeking a Regional Field Action Coordinator (RFAC) to support and advance the EMEA Field Action Process as a Quality System Specialist. This role will ensure smooth execution of field actions, adherence to Quality System requirements, and drive process improvements across EMEA, Middle East, and Africa.
Working closely with Global Quality FA teams, cross-functional stakeholders (including Marketing, Regulatory Affairs, and Customer Care), you will ensure process efficiency while maintaining compliance with regulatory, customer, and corporate standards.
Key Partnerships:
- Regional & in-country Quality teams
- Cross-functional teams (Regulatory, Quality, Customer Care)
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This is a hybrid role (3 days on-site, 2 days remote) with Belgium as the primary location, plus frequent travel.
Key Responsibilities
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Field Action Execution:
- Oversee the EMEA Regional Field Action Process in alignment with Quality System procedures.
- Collaborate with Regulatory, Quality, and Customer Care teams to ensure stakeholder alignment and execution.
- Represent the EMEA Quality Regional FA Team in cross-functional meetings and process improvements.
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Process Improvement & Optimization:
- Support EMEA Field Action process improvements to enhance efficiency.
- Assist with audits and inspections related to field action processes.
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Documentation & Compliance:
- Ensure timely and accurate NCEP/CAPA investigations in line with Field Action Process standards.
- Maintain compliance with regulatory expectations.
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Communication & Decision-Making:
- Communicate clearly to all organisational levels, tailoring messages to the audience’s needs.
- Influence decision-making by presenting risk assessments, trade-offs, and business impact.
Qualifications & Key Requirements
- 5–7 years of experience in Quality System Management, preferably within medical device industry or a related field.
- Deep understanding of Field Action execution processes.
- Strong experience in cross-functional collaboration within a global matrix environment.
- Proven ability to lead initiatives collaboratively to completion.
- Excellent interpersonal skills, stakeholder management, and high influencing capability.
- Strong decision-making, prioritisation, problem-solving, and time management abilities.
- Adaptable to a fast-paced, dynamic environment with a heightened sense of urgency.
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Why Join Boston Scientific?
As a pioneer in medical science for over 40 years, we solve the most pressing healthcare challenges—united by a deep commitment to human life. Our mission: "Advance science for life"—means:
✔ Transforming patient lives through innovation. ✔ Providing value to customers while supporting employees and communities worldwide. ✔ Applying ethical values as a global corporate leader.
A career at Boston Scientific isn’t just a job—it’s a responsibility to improve lives worldwide. Are you ready to make an impact?
Requisition ID: 629246 Apply now: [Link or prompt omitted as per instructions]
(For more information, visit Boston Scientific’s careers page.)
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