Senior Quality Engineer, Global Post Market - Intake

Boston Scientific•Arden Hills, MN

3d•$85,000 - $161,500•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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

Responsibilities

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.