Senior Quality Systems Engineer

Additional Location(s): US-MN-Arden Hills; US-MA-Marlborough; US-MN-Maple Grove 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 Senior Quality Systems Engineer of material controls will serve as a Quality representative to improve awareness, visibility and communication on quality initiatives and objectives, and will support assigned departmental, functional, site, divisional and corporate quality goals and priorities.  Specifically, this role will support the Material (Supplier) controls processes, ensuring compliance to Medical Device regulations and BSC Quality System requirements.

Work Mode:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

Relocation Assistance:

Relocation assistance is not available for this position at this time.

Visa Sponsorship:

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time

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 Ownership of highly visible, global, systemic CAPAs while leading through a Community of Practice Providing guidance to functional members and teams on in area of process ownership, such as supplier audit/AVL, material qualification, procurement, supplier change and corrective action through audit support 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

Required Qualifications:

Minimum of a Bachelor's degree with 5 years of related experience or minimum of a Masters degree with 3 years of related experience 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

Must be willing to travel 25% of the time Technical writing and documentation skills

Preferred Qualifications Degree(s) in Science or Engineering5+ years of experience in Supplier Quality, Supplier Management, or Quality Systems Training/certifications in Quality Management System Requirements (ISO 13485) and FDA…