Senior Quality Systems Engineer

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: 

The Global Principal Quality Systems Engineer of Material Controls is an exciting opportunity to work within a high performing team ensuring best in class compliance and quality system processes while enabling growth through governing agile processes for the business.  This role serves as a key thought leader and driver of global quality system initiatives supporting Boston Scientifics BEST4 strategies and is seen as a highly visible expert in their area of expertise. Specifically, this role will support the Material (Supplier) controls processes focused on Material Qualification, acceptance and change management, ensuring compliance to Medical Device regulations and BSC Quality System requirements. 

Your Responsibilities Will Include: 

• Leadership of cross functional projects teams 

• Using project management best practices to effectively coordinate activities, communicate progress, collaborate on key deliverables and meet critical phase timelines 

• Driving continuous improvement and globalization by gaining alignment across multiple functional departments while meeting BSC and regulation requirements 

• Communicating and Influencing across the BSC Global Sourcing organization to deliver long term strategic outcomes 

• Providing continuous and rigorous assessment of Material Controls processes and review of documentation throughout the material controls processes to ensure compliance with global BSC processes, FDA regulations, ISO 13485, and Medical Device Requirements 

• Collaborating cross functionally to set strategy, priority, and resources with other functions including Commercial Sourcing, Supplier Engineering, Supplier Quality, Purchasing, Design Assurance, and R&D  

• Ownership of highly visible, global, systemic CAPAs while leading through a Community of Practice 

• Providing guidance to functional members, and teams, on area of process ownership such as, material qualification, ongoing acceptance, supplier change, and CAPA processes 

• Determining and tracking actionable material controls metrics and trends to ensure proper execution and effectiveness of the global process 

• Participates or leads in appropriate BSC Communities of Practice to ensure the global processes continuously executes process outputs at the highest industry/company level and anticipates emerging regulatory lines of questioning. 

• Supporting both site and global scale CAPA initiatives, continuous improvement opportunities and/or projects 

Minimum Qualifications:

• Bachelor's degree engineering or related field 

• 5+ years of experience in a medical device manufacturing, quality or regulatory/compliance environment 

• Previous experience in a Supplier Quality, Supplier Engineering, or Sourcing organization 

• Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485 

• Technical writing and documentation skills 

• Advance English Level  

• Submit resume in English 

Preferred Qualifications:

• Training/certifications in Quality Management System Requirements (ISO 13485) and FDA Quality System Regulation (21 CFR Part 820) 

• Project management skills 

Requisition ID: 611839

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!