Boston Scientific Senior Quality Systems Engineer 

United States, Minnesota, Maple Grove 

721751737

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 Management System and the Strategic Quality Process
  

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.