Senior Quality Systems Engineer

Boston Scientific•Arden Hills, MN

11d•$85,000 - $161,500•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 departmental, functional, site, divisional, and corporate quality goals. The role supports Material (Supplier) Controls processes and ensures compliance with medical device regulations and Boston Scientific Quality System requirements. This hybrid role requires employees to work from a local office at least three days per week. The listed locations are Arden Hills, Minnesota; Marlborough, Massachusetts; and Maple Grove, Minnesota. Travel is required 25% of the time. Relocation assistance and visa sponsorship are not available. The role leads cross-functional projects and global process improvements, supports material controls processes and documentation, and provides guidance on supplier audit/AVL, material qualification, procurement, supplier change, and corrective action. It also owns visible global systemic CAPAs, tracks process metrics and trends, and participates in Communities of Practice to maintain effective processes and anticipate regulatory scrutiny.

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 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.
Use project management best practices to coordinate activities, communicate progress, collaborate on deliverables, and meet phase timelines.
Drive continuous improvement and globalization by aligning multiple functional departments while meeting company and regulatory requirements.
Communicate and influence across the Global Sourcing organization to deliver long-term strategic outcomes.
Assess Material Controls processes and review documentation for compliance with global company 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 on 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 monitor global process execution and effectiveness.
Participate in or lead Communities of Practice to support high-quality global process execution and anticipate emerging regulatory questions.
Support site- and global-scale CAPA initiatives, continuous improvement opportunities, and projects.