Senior Quality Systems Engineer

The Senior Quality Systems Engineer provides technical leadership and subject matter expertise in the development, maintenance, and continuous improvement of the Quality Management System (QMS), ensuring compliance with applicable regulatory

and industry standards.

This is a hybrid work mode position located in Maple Grove, MN at the Arbor Lakes Site Location with the expectation to be in the office 3 days per week.

Your

and standards, including FDA QMSR, ISO 13485, ISO 14971, and EU MDR.

• ✓Mentor teams leading complex investigations, root-cause analysis, corrective actions, and effectiveness verification.
• ✓Support internal and external audits and regulatory inspections, including site preparation, SME readiness, finding responses, and remediation activities.
• ✓Analyze quality metrics and trends to identify systemic risks and drive data-based improvements.
• ✓Lead continuous improvement initiatives to enhance QMS effectiveness, compliance, and operational efficiency.
• ✓Partner cross-functionally with Engineering, R&D, Regulatory, Operations, and other stakeholders to resolve quality issues and implement sustainable solutions.
• ✓Develop and maintain quality procedures, work instructions, and other controlled documentation.
• ✓Apply risk-based decision-making to quality and compliance issues.
• ✓Serve as a QMS subject matter expert, providing guidance, training, and mentorship to cross-functional team members across the site.
• ✓Lead quality-system projects and influence stakeholders to ensure timely, compliant, and effective execution.
• ✓Partner with Global teams to influence and drive continual improvement within the QMS.

• ✓Bachelor's degree and 5+ years or Master's degree and 3+ years of experience in a medical device manufacturing, quality or regulatory/compliance environment
• ✓Understanding of quality system

as stated within FDA QMSR, ISO 13485, ISO 14971, and EU MDR

• ✓Technical writing and documentation skills
• ✓Attention to detail and ability to analyze information quickly
• ✓Use a risk-based approach for making quality and business decisions

• ✓Proactive, able to work independently, as a team leader or member, and enjoy being part of a highly visible team
• ✓Ability to collaborate and communicate with all levels of the organization
• ✓Continuous improvement mindset with a passion for Quality
• ✓Degree(s) in Science or Engineering
• ✓5+ years of experience in Quality Systems
• ✓Training/certifications in Quality Management System

(ISO 13485) and FDA Quality Management System Regulation

• ✓Hands-on Project Management experience

Maximum Salary: $ 161500

For MA positions : It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Among other requirements, Boston Scientific maintains specific prohibited substance test

for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.