Senior Quality Engineer, Global Post Market - Intake

Senior Quality 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.

The Senior Quality Engineer provides quality engineering support for manufacturing and product development, helping ensure the delivery of the highest-quality products to our patients. In this role, you will partner with cross-functional teams to improve manufacturing processes, strengthen quality systems and support the development of innovative medical technologies.

As a senior technical contributor, you will lead quality initiatives across the product life cycle, influence process improvements and ensure compliance with global regulatory requirements. This position offers the opportunity to make a meaningful impact on patient safety while collaborating with teams across Engineering, Manufacturing, Operations and Quality.

This position follows an on-site work model and requires employees to work from the local Boston Scientific office on a full-time basis. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

• Provide quality engineering support for manufacturing and new product development to ensure products meet customer, regulatory and business requirements.
• Develop and implement product quality plans, product specifications, quality specifications, risk analyses and failure mode and effects analyses (FMEAs) in collaboration with cross-functional product development teams.
• Serve as a subject matter expert for the complaint intake process within the global complaint handling system, supporting process execution, continuous improvement and regulatory compliance.
• Monitor and evaluate global complaint records from multiple complaint sources and designated reporting locations to ensure timely and accurate event intake.
• Lead or support global strategic quality initiatives as a project owner, subject matter expert or cross-functional team member.
• Own and participate in nonconformance evaluations and corrective and preventive action (CAPA) activities to drive effective issue resolution and continuous improvement.
• Develop quality tools, procedures and training materials that promote consistent application of quality system requirements and best practices.
• Evaluate the effectiveness and compliance of quality systems, operations and manufacturing practices against applicable regulations and internal procedures.
• Support internal and external audits, including serving as the quality representative during audit activities.
• Apply analytical and systematic problem-solving methodologies to identify risks, investigate complex quality issues and implement sustainable solutions.
• Partner with cross-functional teams to improve quality, reduce risk and drive operational excellence.
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Boston Scientific Quality Policy and all documented quality system requirements.

Qualifications:

Required qualifications:

• Minimum of a bachelor's degree in engineering, science or a related technical discipline.
• Minimum of 5 years' experience in a regulated manufacturing industry.
• Experience supporting quality systems, complaint handling, post-market surveillance or manufacturing quality within a regulated industry.
• Experience leading or supporting corrective and preventive action (CAPA) investigations and root cause analysis.
• Experience performing risk management activities, including risk analyses and failure mode and effects analyses (FMEAs).
• Experience interpreting and applying quality system and regulatory requirements within a regulated industry.
• Experience collaborating with cross-functional teams to support manufacturing, product development or quality improvement initiatives.

Preferred qualifications:

• Experience in the medical device industry.
• Experience supporting new product development and design controls.
• Experience leading cross-functional quality or continuous improvement projects.
• Knowledge of statistical analysis tools, including Minitab and Microsoft Excel.
• ASQ Certified Quality Engineer (CQE) or another relevant quality certification.
• Demonstrated ability to influence cross-functional teams and lead technical initiative