Quality System Engineer III

Diversidad - Innovación - Preocupación - Colaboración global - Espíritu ganador - Preocupación - Alto rendimiento

En Boston Scientific, le brindaremos la oportunidad de aprovechar todo lo que hay dentro de usted trabajando en equipos de empleados diversos y de alto rendimiento, abordando algunos de los desafíos más importantes de la industria de la salud. Con acceso a las últimas herramientas, información y capacitación, lo ayudaremos a mejorar sus habilidades y su carrera. Aquí, recibirá apoyo para progresar, sean cuales sean sus ambiciones.  

About the role:

Develop, implement, maintain, and improve appropriate quality system elements to ensure the high-quality level of new and existing products. Provide support to internal and external audits (including unannounced audits/inspections), internal/external audit findings, and Case for Quality annual appraisals. Provide support to Quality Planning to ensure flawless execution of the subprocess, providing tracking and follow-up for timely closure of site QPTPs/QSPD as required to avoid impact to metrics. Also, will support Open Loops forum to help gather information and track timely resolution of red metrics. Overall support to other Quality Systems subprocesses for the site will be provided by this role. Provide guidance and support for other day-to-day activities within the department. Serves as a Quality representative to improve awareness, visibility and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals, and priorities. 

Your responsibilities include:

• Execute and support internal and external audit activities, as well as lead internal audits. 
• Monitor and track the progress of internal audits tasks and initiatives. Collaborate and follow up with team members to ensure completion of assigned tasks within established timelines.  
• Monitor and track site metrics related to internal and external audits, contribute to Quarterly Management Review (QMR) meeting deliverables and follow up on action items. 
• Collaborate with NCEP and CAPA owners on documentation, timelines, and eCAPA system use, to prioritize tasks and ensure content is clear/well-documented, especially when related to internal/external audits.  
• Apply sound, systematic problem-solving methodologies to support teams in identifying, prioritizing, communicating, and resolving quality issues.   
• Act as an effective leader or team member in supporting quality disciplines, decisions, and practices. 
• Create, revise, and approve departmental procedures and quality system records.      

Minimum Requirements:

• Bachelor’s degree in engineering, or a related field.  
• 3+ years’ experience in the medical device industry with a solid understanding of QSR and ISO 13485 Quality System requirements 
• English level B2 or above 
• Excellent verbal and written communication skills  
• Proficiency in MS-Office (Word, Excel, PowerPoint, Project, Visio)  

Preferred Requirements:

• Experience with internal and external audits. 
• Project/task management experience  
• Experience with Product Lifecycle Management systems (i.e. Windchill, PLM)  
• Experience with nonconformance and/or CAPA process  
• Experience with AI tools (MS Copilot, ChatGPT) and/or data management dashboards (Power BI, Tableau) 

Númerode la requisición: 609079

Como líder en ciencia médica durante más de 40 años, estamos comprometidos a resolver los desafíos que más importan, unidos por un profundo cuidado por la vida humana. Nuestra misión de promover la ciencia de por vida consiste en transformar vidas a través de soluciones médicas innovadoras que mejoran la vida de los pacientes, crean valor para nuestros clientes y apoyan a nuestros empleados y las comunidades en las que operamos. Ahora más que nunca, tenemos la responsabilidad de aplicar esos valores a todo lo que hacemos, como empresa global y como ciudadano corporativo global.