Senior Quality Systems Engineer

Additional Location(s):  N/A

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 focus of this Senior Quality Systems Engineer position will be on monitoring and driving continuous improvement in application of the Maple Grove Quality System. This position will involve leading and/or supporting Quality System activities related to Quality System Management including Quality Management Review, Quality Planning, and External Audit. Additionally, this role will include coordination, monitoring, and support of site-wide cross-functional projects that support departmental, site, and corporate quality initiatives. Examples include QMS Optimization projects, leading the MG Process/Sub-Process Owner Community of Practice (CoP), supporting/coordinating sitewide CAPA activities, Quality Systems/Regulation Training development, supporting divisional (IC and PI) and site Management Controls activities including development of goals objectives, and being an active participant on CoP Projects. 

Your responsibilities will include:

• Leading and supporting Maple Grove and IC/PI Divisional Quality System enhancement projects and continuous improvement initiatives including:
• Communicating and influencing the Maple Grove Site and applicable Communities of Practice to deliver long term strategic outcomes
• Utilization of project management best practices to effectively coordinate activities, communicate progress, collaborate on key deliverables, and meet timelines
• Driving continuous improvement and globalization by gaining alignment across stakeholders/functions while meeting BSC and regulation requirements
• Resolving project roadblocks and obstacles by working with team members, project customers, others, and escalating to management as appropriate
• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
• Coordinating the creation of and subsequently facilitating the execution of the Maple Grove Feeder System Review and Quarterly Management Reviews
• Participating in Management Controls and Quality Planning Global Communities of Practice to ensure the Global Processes are understood and best practices are applied at Maple Grove
• Being a subject matter expert in matters relating to application of the BSC Global Quality Management System at the Maple Grove site with the ability to make sound decisions and provide guidance regarding how to best apply the processes efficiently, effectively, and compliantly
• Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and quality issues and driving continuous improvement 
• Support and communication/coordination of high visibility sitewide CAPAs
• Supporting External Audits

What we’re looking for in you:
Required Qualifications

• Bachelor’s degree and 5+ years relevant experience, preferably in medical device industry
• Team mentality
• Must be proactive, able to work independently, as a team leader or member, and enjoy being part of a highly visible team
• Excellent verbal and written communication, interpersonal, organizational, and presentation skills; must be able to multi-task and work well under deadlines
• Attention to detail and ability to analyze information quickly
• Ability to collaborate and communicate with all levels of the organization
• Use a risk-based approach for making quality and business decisions
• Hands-on Project Management experience
• Working knowledge of ISO 13485,21 CFR Part 820, and EU MDR 2017/745 with ability to understand procedural documents and evaluated documents to ensure compliance to all applicable regulations and requirements
• Continuous improvement mindset with a passion for Quality

Preferred Qualifications

• Bachelor Degree in Science or Engineering
• 5+ years of experience in Quality Systems
• Understanding of additional regulations and standards: ISO 14971, MDD, MHLW, SOR/98-282, Therapeutic Goods Regulations 2002, Resolution RDC No 16, 21 CFR Part 4 and 21 CFR Part 211, as applicable
• Training/certifications in Quality Management System Requirements (ISO 13485), FDA Quality System Regulation (21 CFR Part 820), auditing, and/or Certified Quality Engineer
• Thorough understanding of the BSC Quality Manage