Senior Quality Engineer, Global Post Market - Intake

About The Role

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.

Work Model & Sponsorship

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.

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.

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 initiatives.

Pay

Minimum Salary: $85,000 | Maximum Salary: $161,500. The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).