Quality Sys Engineer III

Boston Scientific; Quincy (MA); Ibrido; USD 82.000 - 156.000; Tempo pieno

Descrizione del lavoro

Boston Scientific is seeking a Quality Systems Engineer III to provide technical leadership in the development, maintenance and continuous improvement of the Quality Management System (QMS). The role partners with cross-functional teams to strengthen quality processes, mitigate risks and drive improvements in regulatory compliance and operational efficiency.

The position follows a hybrid work model requiring in-office presence at least three days per week in the United States.

Competenze

• Bachelor's degree and minimum 5 years' relevant experience.
• Working knowledge of FDA QMSR and ISO 13485 requirements.
• Demonstrated technical writing skills for compliant QC documentation.
• Experience applying risk-based approaches to quality decisions.
• Ability to work in the United States without current or future employer sponsorship.

Mansioni

• Lead and support QMS processes, including CAPA, nonconforming events, internal and external audits, and management review.
• Ensure compliance with regulatory requirements and standards (FDA QMSR, ISO 13485, ISO 14971).
• Provide guidance on investigations, root cause analysis, corrective actions and effectiveness verification.
• Support regulatory inspections and audits, including site readiness and remediation activities.
• Analyze quality metrics and trends to identify systemic risks and drive data-informed improvements.
• Lead continuous improvement initiatives to enhance QMS effectiveness and operational efficiency.
• Collaborate with engineering and operations to resolve quality issues and implement sustainable solutions.
• Develop, review and maintain quality procedures and controlled documents.
• Apply risk-based decision-making to quality and compliance issues.

Conoscenze

Technical writing

Quality data analysis

Risk-based decision-making

CAPA management

Root cause analysis

Cross-functional collaboration

Formazione

Bachelor's degree

Master's degree

Descrizione del lavoro

Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.About the role:Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work.Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.The Quality Systems Engineer III provides technical leadership and subject matter expertise in the development, maintenance and continuous improvement of the Quality Management System (QMS). This role supports distribution center and site quality system activities while ensuring compliance with applicable regulatory requirements and industry standards.In this role, you will collaborate with cross-functional teams to strengthen quality processes, mitigate risks and drive sustainable improvements that support Boston Scientific's commitment to delivering high-quality medical technologies.Work model, sponsorship, relocation:At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. 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.Your responsibilities will include:Lead and support QMS processes, including corrective and preventive action (CAPA), nonconforming events, internal and external audits, and management review.Ensure compliance with applicable regulatory requirements and standards, including FDA Quality Management System Regulation (QMSR), ISO 13485 and ISO 14971.Provide technical guidance and mentorship on complex investigations, root cause analysis, corrective actions and effectiveness verification.Support internal and external audits and regulatory inspections, including site preparation, subject matter expert readiness, responses to findings and remediation activities.Analyze quality metrics and trends to identify systemic risks, evaluate performance and drive data-informed improvements.Lead continuous improvement initiatives to enhance QMS effectiveness, regulatory compliance and operational efficiency.Collaborate with engineering, operations and cross-functional stakeholders to resolve quality issues and implement sustainable solutions.Develop, review and maintain quality procedures, work instructions and other controlled documentation.Apply risk-based decision-making to quality and compliance issues to support effective and sustainable outcomes.Serve as a QMS subject matter expert, providing technical guidance and training to cross-functional teams.Lead quality system projects, influence stakeholders and ensure timely, compliant and effective execution.Partner with global teams to identify opportunities and drive continuous improvement across the QMS.Qualifications:Required qualifications:Bachelor's degree and a minimum of 5 years' relevant experience, or a master's degree.Working knowledge of FDA QMSR and ISO 13485 requirements.Demonstrated technical writing skills, including the ability to develop and maintain clear, accurate and compliant quality documentation.Demonstrated ability to analyze quality data, identify trends and determine appropriate corrective or preventive actions.Experience applying risk-based approaches to quality and business decisions.Ability to work in the United States without current or future employer sponsorship.Preferred qualifications:Degree in science, engineering or a related technical discipline.Minimum of 3 years' experience in quality systems.Experience with CAPA, nonconformance management, internal and external audits, and management review processes.Training or certification related to ISO 13485 and FDA quality management system requirements.Experience managing projects, coordinating cross-functional activities and driving initiatives to completion.Demonstrated ability to communicate effectively and collaborate across functions and organizational levels.Experience leading continuous improvement initiatives to enhance quality system performance and operational effectiveness.Requisition ID: 636961Minimum Salary: $ 82100Maximum Salary: $ 156000The 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.Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.