Senior Quality Systems Engineer

Senior Quality Systems Engineer

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 Senior Quality Systems Engineer supports the Global Quality Systems and Acquisition Integration team within the Document and Records Control function. This role provides global process and digital system support, partnering with IT and cross-functional stakeholders to maintain compliance, drive continuous improvement and ensure effective quality system performance. The position contributes to the development, maintenance and enhancement of quality system processes and tools that support compliant information lifecycle management across Boston Scientific.

This role follows a hybrid work model requiring employees to be in our local office Marlborough, MA or Arden Hills, MN or Maple Grove, MN. at least three days per week. 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.

Your responsibilities will include:

• Global quality process and compliance ownership
• Digital quality systems and IT partnership
• Continuous improvement and operational excellence
• Quality events, CAPA and risk management
• Project leadership and global collaboration
• Audit and regulatory support
• Leadership, mentorship and training

Required qualifications:

• Minimum of Bachelor's degree in Engineering, quality, life sciences or a related field.
• Minimum 5 years' experience in quality systems within a regulated industry
• Working knowledge of regulations and standards applicable to the Boston Scientific Global Quality System and Document and Records Control processes, including ISO 13485, 21 CFR Part 820 and EU MDR.
• Demonstrated experience partnering with cross-functional stakeholders to support quality system processes and digital tools
• Previous experience or open to learning digital product ownership, quality systems application support and/or IT project experience

Preferred qualifications:

• Medical device industry experience preferred
• Prior document control and records management experience preferred
• Proven experience supporting audits, inspections and CAPA activities

Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.