[Remote] Quality Systems Engineer III Job Details | Boston Scientific
Note: The job is a remote job and is open to candidates in USA. Boston Scientific is a global medical technology company that develops innovative devices and therapies to improve patient health. The Quality Systems Engineer III develops and maintains quality engineering systems, supports product development and manufacturing operations, and ensures compliance with customer and regulatory requirements. The role also leads quality assurance, process control, CAPA, problem-solving, and continuous improvement initiatives.
Responsibilities
- 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
Skills
- ● 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
- ● 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
Benefits
- With access to the latest tools, information and training, we’ll help you in advancing your skills and career.
- 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.
- 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).
Company Overview
