Quality Systems Engineer III

Quality Systems Engineer III

Work mode:
Hybrid Onsite Location(s):
Indianapolis, IN, US, 46201 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.

About the role:

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. The Quality Engineer develops, establishes and maintains quality engineering methodologies, systems and practices that meet Boston Scientific, customer and regulatory requirements.

This role serves as a quality representative to improve awareness, visibility and communication of quality initiatives that support departmental, functional, site, divisional and corporate quality goals. The position provides focused quality engineering support for new product development, operations and quality systems while maintaining an unwavering commitment to patient safety and product quality.

Work model, sponsorship, relocation:
This position is remote until the new Plainfield, Indiana, site opens, which is expected in summer 2027. Following the site opening, the role will transition to the Plainfield location. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

During the first year, the individual must be able and willing to travel between Quincy, Massachusetts, and Plainfield, Indiana, as business needs require.

Your responsibilities will include:
Develop, establish and maintain quality engineering methodologies, systems and practices that meet Boston Scientific, customer and regulatory requirements. Serve as the quality representative to promote awareness, visibility and communication of quality initiatives across departmental, functional, site, divisional and corporate teams. Identify and implement effective process control systems that support product development, process qualification and ongoing manufacturing performance. Lead the implementation of quality assurance activities, process controls and CAPA systems to meet or exceed internal and external requirements.

Partner with cross-functional teams to support quality disciplines, decisions and best practices throughout the product life cycle. Apply systematic problem-solving methodologies to identify, prioritize, communicate and resolve quality issues. Support the development and execution of efficient business systems that proactively identify and resolve quality concerns. Maintain compliance with the Boston Scientific Quality Policy and all documented quality system processes and procedures, demonstrating a primary commitment to patient safety and product quality.

Support continuous improvement initiatives that enhance product quality, compliance and operational effectiveness. Organize, analyze and present quality data to influence decision-making with internal stakeholders.

Qualifications:

Required qualifications:

Bachelor's degree in engineering or a related technical discipline. Solid knowledge of quality engineering principles, methodologies and quality system requirements. Working knowledge of process controls, CAPA, root cause analysis and continuous improvement methodologies. Ability to analyze technical problems, evaluate alternatives and implement effective solutions. Strong written and verbal communication skills with the ability to present technical information clearly to internal audiences.

Ability to organize and analyze data to support quality and business decisions. Ability to work effectively on cross-functional teams and build collaborative relationships. Willingness and ability to travel between Quincy, Massachusetts, and Plainfield, Indiana, during the first year of employment.

Preferred qualifications:

Experience supporting new product development, manufacturing operations or quality systems within a regulated industry. Experience working in a medical device, pharmaceutical or other FDA-regulated environment. Knowledge of applicable regulatory standards and quality system requirements. Experience supporting process validation, risk management and continuous improvement initiatives.