Additional Location(s): N/A

About the role:

The Quality Engineer develops, establishes and maintains quality engineering methodologies, systems and practices that meet Boston Scientific, customer and regulatory requirements. This role serves as a quality representative to improve awareness, visibility and communication of quality initiatives that support departmental, functional, site, divisional and corporate quality goals. The position provides focused quality engineering support for new product development, operations and quality systems while maintaining an unwavering commitment to patient safety and product quality.

Work model, sponsorship, relocation:

This position is remote until the new Plainfield, Indiana, site opens, which is expected in summer 2027. Following the site opening, the role will transition to the Plainfield location. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time. During the first year, the individual must be able and willing to travel between Quincy, Massachusetts, and Plainfield, Indiana, as business needs require.

Your responsibilities will include:
• Develop, establish and maintain quality engineering methodologies, systems and practices that meet Boston Scientific, customer and regulatory requirements.
• Serve as the quality representative to promote awareness, visibility and communication of quality initiatives across departmental, functional, site, divisional and corporate teams.
• Identify and implement effective process control systems that support product development, process qualification and ongoing manufacturing performance.
• Lead the implementation of quality assurance activities, process controls and CAPA systems to meet or exceed internal and external requirements.
• Partner with cross-functional teams to support quality disciplines, decisions and best practices throughout the product life cycle.
• Apply systematic problem-solving methodologies to identify, prioritize, communicate and resolve quality issues.
• Support the development and execution of efficient business systems that proactively identify and resolve quality concerns.
• Maintain compliance with the Boston Scientific Quality Policy and all documented quality system processes and procedures, demonstrating a primary commitment to patient safety and product quality.
• Support continuous improvement initiatives that enhance product quality, compliance and operational effectiveness.
• Organize, analyze and present quality data to influence decision-making with internal stakeholders.

Qualifications:

Required qualifications:
• Bachelor's degree in engineering or a related technical discipline.
• Solid knowledge of quality engineering principles, methodologies and quality system requirements.
• Working knowledge of process controls, CAPA, root cause analysis and continuous improvement methodologies.
• Ability to analyze technical problems, evaluate alternatives and implement effective solutions.
• Strong written and verbal communication skills with the ability to present technical information clearly to internal audiences.
• Ability to organize and analyze data to support quality and business decisions.
• Ability to work effectively on cross-functional teams and build collaborative relationships.
• Willingness and ability to travel between Quincy, Massachusetts, and Plainfield, Indiana, during the first year of employment.

Preferred qualifications:
• Experience supporting new product development, manufacturing operations or quality systems within a regulated industry.
• Experience working in a medical device, pharmaceutical or other FDA-regulated environment.
• Knowledge of applicable regulatory standards and quality system requirements.
• Experience supporting process validation, risk management and continuous improvement initiatives.

Requisition ID: 632651

Minimum Salary: $ 82100

Maximum Salary: $ 156000

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-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).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.