Boston Scientific Quality System Engineer III 

Costa Rica, Alajuela Province, El Amparo 

504125796

Costa Rica-Coyol

About the role:

Develop, implement, maintain and improve appropriate quality system elements to ensure the high-quality level of new and existing products. Provide guidance and support to NCEP and CAPA owners for documentation, timelines, and eCAPA system use. Provide guidance and support for other day-to-day activities within the department. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.

Your responsibilities include:

• Provide Quality Engineering support for sustaining activities and improvement projects for commercial products, with a focus on Non-Conformance Event Prevention (NCEP) and Corrective and Preventive Actions (CAPA).

• Collaborate with NCEP and CAPA owners on documentation, timelines, and eCAPA system use, to prioritize tasks and ensure content is clear/well-documented.

• Perform failure analyses and defect investigations as needed. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues and approve material dispositions.

• Perform and/or lead risk analyses and failure investigations for CAPA and/or audit finding investigations. Act as an effective leader of team member in supporting quality disciplines, decisions and practices.

• Create, revise, and approve departmental procedures and quality system records. Lead in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements.

• Design and implement Quality System processes, procedures, and techniques such as risk assessment, root cause analysis, etc.

• Monitor and track the progress of quality-related tasks and initiatives, with a focus on NCEP and CAPA records. Collaborate and follow up with team members to ensure completion of assigned tasks within established timelines.

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)

• Strong technical writing skills and ability to clearly communicate complex information

Preferred qualifications:

• Project/task management experience

• Experience with Product Lifecycle Management systems (i.e. Windchill, PLM)

• Experience with nonconformance and/or CAPA process