Quality System Specialist - Field Action (FA) Process
£32.5 - £37.7 per hourEstimated
Full-time
Additional Locations: Spain-Madrid; Italy-Milan; United Kingdom-Hemel Hempstead 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 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. This a a hybrid position, which means working three days from the office and two days from home. Key Responsibilities
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 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. This a a hybrid position, which means working three days from the office and two days from home. 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.
- 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.
Vacancy posted 18 days ago
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