Senior Quality System Specialist - Field Action (FA) Process

Boston Scientific Gruppe; Hemel Hempstead; On-site; GBP 45,000 - 70,000; Full time

Job summary

A global medical device leader in Hemel Hempstead is looking for a Senior Quality System Specialist to manage Field Action processes. The role involves collaboration with cross-functional teams, managing process improvement initiatives, and ensuring compliance with quality standards. Candidates should have 5–7 years of experience in Quality System Management and strong communication skills. This position offers an opportunity to make a significant impact within the organization.

Qualifications

• 5–7 years of experience in Quality System Management within the medical device or related industry.
• Knowledge of the Field Action execution process.
• Demonstrated ability to collaborate effectively in a global, matrixed organization.
• Experience leading cross-functional initiatives to completion.
• Ability to work independently and within a team in a dynamic environment.

Responsibilities

• Manage the EMEA Regional Field Action process execution steps in accordance with defined procedures.
• Collaborate with cross-functional teams to ensure stakeholder understanding and expectations.
• Support the execution of EMEA FA process improvement initiatives.
• Communicate effectively across all levels of the organization.
• Assist with audits and inspections related to field action processes.

Skills

Quality System Management

Collaboration

Decision-making

Problem-solving

Communication

Influencing

Job description

Senior Quality System Specialist - Field Action (FA) Process

Onsite Location(s): Hemel Hempstead, GB

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Background

We are seeking an additional resource to support Field Action execution and to drive ongoing FA related process improvement initiatives, within the European, Middle East and Africa (EMEA) Region.

Role Overview

The Senior Quality System Specialist will play a pivotal role as a Regional Field Action Coordinator (RFAC), supporting the EMEA Field Action Process. This individual will be part of a dedicated team responsible for planning, executing, and closing field actions, as well as identifying and implementing process improvement initiatives in collaboration with impacted stakeholders.

This role involves close partnership with Global, Regional, and in-country Quality FA teams, as well as cross-functional stakeholders in Marketing, Regulatory Affairs, and Customer Care. Success in this position requires excellent interpersonal skills and stakeholder management experience, with a strong focus on process efficiency, while ensuring adherence to quality system requirements that meet Boston Scientific, customer, and regulatory expectations.

The ideal candidate will be based near a Boston Scientific EMEA hub, office, or manufacturing site.

Key Responsibilities

• Manage the EMEA Regional Field Action process execution steps in accordance with defined procedures.
• Collaborate with cross-functional teams (Regulatory, Quality, Customer Care) to ensure stakeholder understanding and expectations in relation to Field Action activities.
• Represent EMEA Quality Regional FA Team in cross-functional meetings and improvement workstreams
• Support the execution of EMEA FA process improvement initiatives.
• Communicate effectively across all levels of the organisation, tailoring messaging to audience.
• Influence decision-making through clear articulation of risks, trade-offs, and business impact.
• Assist with audits and inspections related to field action processes.
• Ensure timely and accurate documentation of NCEP/CAPA investigations in accordance with established procedures in relation to the Field Action Process.

Qualifications & Requirements

• 5–7 years of experience in Quality System Management within the medical device or related industry.
• Knowledge of the Field Action execution process.
• Demonstrated ability to collaborate effectively in a global, matrixed organization.
• Experience leading cross-functional initiatives to completion.
• Ability to work independently, and within a team, in a dynamic environment.
• Strong interpersonal, communication, and influencing skills.
• Excellent decision-making, prioritization, problem-solving, and time management abilities.
• High sense of urgency and commitment to execution in a fast-paced setting.

Requisition ID: 615207

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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