Senior Quality Systems Engineer

bostonscientific•Maple Grove, MA

9d•Hybrid

About The Position

Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work. Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. We are seeking a Senior Quality Systems Engineer to serve as a Global Risk Management Process Owner within the Global Quality Systems organization. In this highly collaborative role, you will lead the governance, development and continuous improvement of Boston Scientific's Global Risk Management process to ensure compliance with internal quality standards and global regulatory requirements. The incumbent will be working across divisions and functions, you will partner with design teams, Global Risk Management sub-process stewards and cross-functional stakeholders to establish standardized processes, strengthen risk management practices and drive enterprise-wide consistency. This role provides an opportunity to influence product quality throughout the product lifecycle while advancing continuous improvement initiatives that support innovation, patient safety and regulatory excellence.

Requirements

Minimum Bachelor's degree in Engineering, Science, Health Sciences or another related discipline.
Minimum of 5 years' experience in medical device Design Controls and Risk Management.
Strong knowledge of Design Controls, Risk Management principles and product lifecycle quality processes.
Working knowledge of FDA Quality Management System Regulation (QMSR), 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR and other applicable global medical device regulations.
Demonstrated experience leading cross-functional initiatives and influencing stakeholders across a global matrix organization.
Strong analytical, problem-solving and decision-making skills.
Excellent written, verbal and presentation skills.

Nice To Haves

Proven experience supporting health care professional (HCP) training programs.
Demonstrated experience supporting internal audits, external audits or regulatory inspections.
Advanced project management skills with demonstrated success managing multiple initiatives and competing priorities.
Demonstrated facilitation and stakeholder engagement skills with experience leading cross-functional teams and Communities of Practice.
Advanced proficiency with Microsoft 365 applications, including Teams, Excel, PowerPoint and Word.
Experience driving continuous improvement initiatives using Lean, Six Sigma or other process improvement methodologies.

Responsibilities

Serve as the Global Risk Management Process Owner, driving strategic initiatives that strengthen process effectiveness, governance and regulatory compliance.
Develop, maintain and continuously improve global procedures, systems and best practices that support product development and lifecycle risk management.
Partner with Global Risk Management sub-process stewards, design teams and cross-functional stakeholders to ensure consistent implementation of enterprise risk management processes.
Lead Global Communities of Practice to promote collaboration, knowledge sharing, process standardization and adoption of best practices across divisions.
Evaluate trends identified through quality system audits, regulatory submissions, management reviews and quality metrics to identify opportunities for process improvements and corrective actions.
Partner with upstream and downstream process owners to maintain effective integration between Global Risk Management and related quality system processes, including Design Controls, Production and Process Controls, Material Controls and Post Market Surveillance.
Support internal audits, external audits and regulatory inspections by providing documentation, process expertise and audit responses.
Monitor compliance with Global Quality System procedures, corporate policies and applicable regulatory requirements.
Lead Global Corrective and Preventive Action (CAPA) activities, including complex, cross-functional and multi-site investigations that drive sustainable process improvements.
Apply structured problem-solving methodologies to identify, prioritize and resolve quality system issues while driving continuous improvement and operational excellence.
Support the development and implementation of streamlined business processes that advance VIP and enterprise continuous improvement objectives.