Global Quality Systems Engineer – Digital Compliance

Boston Scientific

Marlboro (MA)

Hybrid

USD 82,000 - 156,000

Full time

3 days ago

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Job summary

Boston Scientific is seeking a Quality Systems Engineer III to support Global Quality Systems and Acquisition Integration. The role collaborates with IT and cross-functional partners to maintain compliance and drive continuous improvement of quality processes.

A Bachelor’s degree and at least three years in quality systems within a regulated environment are required; knowledge of ISO 13485, 21 CFR Part 820 and EU MDR, plus experience with digital tools or PLM systems such as Windchill, is

Qualifications

Bachelor's degree in a relevant field.
At least 3 years' experience in quality systems within a regulated industry.
Working knowledge of ISO 13485, 21 CFR Part 820 and EU MDR.
Demonstrated experience partnering with cross-functional stakeholders to support quality system processes and digital tools.
Experience with digital product ownership, quality systems application support and/or IT project experience.

Responsibilities

Global quality process and compliance ownership within a global governance framework.
Digital quality systems and IT partnership to support document and records control processes.
Continuous improvement initiatives to drive efficiency and operations excellence.
Quality events, CAPA and risk management activities and documentation.
Project leadership and global collaboration on quality system projects and acquisitions.
Audit and regulatory support through preparation, execution and follow-up activities.
Leadership, mentorship, and training for Quality Systems Engineers.