Quality Engineer I - Coyol

Additional Locations: Costa Rica-Coyol

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.

About this role:

Responsible for providing technical acumen and data analysis for the Endoscopy division of Boston Scientific for Post Market Reporting assessments (Periodic Safety Updates). The analysis and reporting directly supports product sustainment activities assessing product performance for trends including signal escalation. The role identifies, analyzes, helps to investigate, monitors and documents trends at a product performance level for post marketing surveillance data as part of the EU MDR reporting requirements. The role communicates and educates management, R&D, marketing, Design Assurance, plant QA, clinical, and other departments, as well as potentially external customers about complaints monitoring trending and product performance. The role will identify, coordinate, and execute project priorities based on business and department objectives and at times at the Global BSC level.

Responsible for identifying and helping with implementing continuous improvements to improve product performance and the post market support processes. This role provides visibility across site, cross division and with divisional leadership.

Your responsibilities will include:

• Analyzing customer complaints, compliance events, clinical data and other post marketing surveillance data by examining the data for patterns and trends and investigating when necessary.
• Investigating potential and/or identified trends or data issues with cross-functional teams across the division.
• Manage potential actions by updating the Post Market report at appropriate intervals and levels by performing, when necessary, a Health Risk Analysis and/or Risk Management Analysis reviews.
• Documenting data reviews, trend analysis, escalations and actions as an output in formal regulatory submission report (PSUR) for Notified Body review and agreement.
• Communicating product performance by formal presentations to management, cross-functional team members, committees and/or design teams, supporting published product performance reports.
• Focusing on continuous improvement by championing and fostering the execution of projects within the local and Global Design Assurance and Post Market organizations to continue to improve process and product performance.
• Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Demonstrating a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.
• Provides input for process improvement and helps develop tactical approaches to implement team strategies.

Minimum Qualifications

• Bachelor’s degree with an Engineering or Science background
• English Level B2 (70-79%). 
• Strong communication and presentation skills. Comfort speaking to groups of individuals.
• Presentation skills that comfortably and concisely translate performance and issues to peer and senior management audiences.
• Demonstrated problem-solving & critical thinking.
• Capable working in a regulated environment with clinical teams including review of clinical data and analysis of clinical terminology
• Advanced knowledge of Microsoft Excel
• Proficient with Microsoft Office tools including Word, PowerPoint, Teams and Outlook
• Ability to collaborate and influence across multiple, cross-functional teams
• Strong ability to successfully multi-task and adaptability
• Attention to detail and accuracy in data analysis and documentation.

Preferred Qualifications

• ISO 13485 or MDR knowledge
• Knowledge of analytical techniques, problem solving, continuous improvement programs, data analytics and statistical analysis
• Demonstrated statistical analysis & data analysis capabilities
• Self-starter with the ability to identify improvement opportunities.
• Experience with and/or knowledge in Quality System Regulations, Medical Device Regulation, and Quality Standards.
• Demonstrated understanding of risk management
• Familiarity with Post Market Surveillance requirements and IT systems
• Experience in working across multiple product areas and cross functionally with DA, R&D and Manufacturing teams
• Professionalism to represent BSC to external entities

Requisition ID: 605368

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.