Quality System Engineer III

Additional Locations: Costa Rica-Coyol

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

At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.

Hybrid Roles:

Boston Scientific's hybrid workplace includes Working from Home and onsite. You will have the opportunity to discuss details in the interview. 

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 

Requisition ID: 605517

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!

Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.