Global Quality Systems Engineer III: Compliance & Digital

Boston Scientific Gruppe; Marlborough (MA); Hybrid; USD 82,000 - 156,000; Full time

Job summary

Boston Scientific is seeking a Quality Systems Engineer III to support global quality systems and acquisition integration within document and records control. The role emphasizes collaboration with IT and stakeholders to maintain compliance, improve processes, and ensure system effectiveness across the organization.

The candidate will drive governance-based process ownership, support audits, CAPA, and risk management, and mentor team members while contributing to the quality systems roadmap

Qualifications

• 3+ years of quality systems experience in a regulated industry.
• Working knowledge of ISO 13485, 21 CFR Part 820 and EU MDR.
• Experience partnering with cross-functional stakeholders to support quality system processes and digital tools.
• Open to learning digital product ownership or IT project experience.

Responsibilities

• Own global quality process and compliance activities within a governance framework.
• Support standardization and audit readiness across regulations and standards.
• Collaborate with IT to configure and enhance digital platforms for document and records control.
• Lead root cause investigations and CAPA activities as needed.
• Support global quality system projects, acquisitions, and process implementations.
• Deliver training and mentor team members on quality system processes and tools.

Skills

Quality systems experience

Cross-functional collaboration

Digital product ownership

IT project experience

Tools

Windchill/PLM

Job description

Boston Scientific is seeking a Quality Systems Engineer III to support global quality systems and acquisition integration within document and records control. The role emphasizes collaboration with IT and stakeholders to maintain compliance, improve processes, and ensure system effectiveness across the organization.

The candidate will drive governance-based process ownership, support audits, CAPA, and risk management, and mentor team members while contributing to the quality systems roadmap