Senior Quality System Specialist - Field Action (FA) Process

Boston Scientific Gruppe; Hemel Hempstead; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading medical technology company in Hemel Hempstead is seeking a Senior Quality System Specialist to manage the EMEA Regional Field Action process. This role involves collaboration with cross-functional teams, ensuring compliance with quality system requirements while driving process improvements. Ideal candidates have 5–7 years of experience in Quality System Management in the medical device field and strong interpersonal skills.

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.

Responsibilities

• Manage the EMEA Regional Field Action process execution in accordance with defined procedures.
• Collaborate with cross‑functional teams to ensure stakeholder understanding.
• Support the execution of EMEA FA process improvement initiatives.

Skills

Quality System Management

Interpersonal skills

Communication skills

Problem-solving

Decision-making

Collaboration

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

Job Segment

Business Process, Medical Device, Regulatory Affairs, Compliance, CAPA, Management, Healthcare, Legal