Senior Quality Systems Engineer

Boston Scientific • Maple Grove, MA

1d • Hybrid

About The Position

The Senior Quality Systems Engineer of material controls serves as a Quality representative, improving awareness, visibility, and communication around quality initiatives and objectives while supporting assigned departmental, functional, site, divisional, and corporate quality goals. The role supports Material (Supplier) Controls processes to ensure compliance with medical device regulations and Boston Scientific Quality System requirements.

This position leads cross-functional projects and drives continuous improvement and globalization of material controls processes. It provides guidance on supplier audit/AVL, material qualification, procurement, supplier change, and corrective action, and owns highly visible global systemic CAPAs. The engineer assesses process execution and documentation, tracks metrics and trends, and participates in Communities of Practice to support effective global processes and readiness for regulatory scrutiny.

The role follows a hybrid work model, with employees required to work in a local office at least three days per week. Travel is required 25% of the time. Relocation assistance and employment visa sponsorship are not available.

Requirements

• Bachelor's degree and at least 5 years of related experience, or a master's degree and at least 3 years of related experience.
• 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 under 21 CFR Part 820 and ISO 13485.
• Willingness to travel 25% of the time.
• Technical writing and documentation skills.

Nice To Haves

• Degree(s) in science or engineering.
• 5 or more years of experience in Supplier Quality, Supplier Management, or Quality Systems.
• Training or certifications in Quality Management System Requirements (ISO 13485) and FDA Quality System Regulation (21 CFR Part 820).
• Project management skills.

Responsibilities

• Lead cross-functional project teams, coordinating activities, communicating progress, collaborating on deliverables, and meeting phase timelines using project management best practices.
• Drive continuous improvement and globalization by aligning multiple functional departments while meeting Boston Scientific and regulatory requirements.
• Communicate and influence across the BSC Global Sourcing organization to deliver long-term strategic outcomes.
• Assess Material Controls processes and review documentation to ensure compliance with global BSC processes, FDA regulations, ISO 13485, and medical device requirements.
• Own highly visible, global, systemic CAPAs and lead through a Community of Practice.
• Guide functional members and teams in process ownership areas, including supplier audit/AVL, material qualification, procurement, supplier change, and corrective action, through audit support and CAPA processes.
• Determine and track actionable Material Controls metrics and trends to ensure proper execution and effectiveness of the global process.
• Participate in or lead appropriate BSC Communities of Practice to support global process execution and anticipate emerging regulatory lines of questioning.
• Support site and global CAPA initiatives, continuous improvement opportunities, and projects.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior