Quality Sys Engineer III
About The Position
The Quality Systems Engineer III provides technical leadership and subject matter expertise in developing, maintaining, and continuously improving the Quality Management System (QMS). The role supports distribution center and site quality system activities while ensuring compliance with applicable regulatory requirements and industry standards. The engineer collaborates with cross-functional and global teams to strengthen quality processes, mitigate risks, and drive sustainable improvements that support the delivery of high-quality medical technologies. This position follows a hybrid work model, with employees required to work from a local office at least three days per week. Boston Scientific will not provide or take over employment visa sponsorship, and relocation assistance is unavailable. The role is designated safety-sensitive and requires prohibited substance testing.
Requirements
- Bachelor's degree and a minimum of 5 years of 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.
- 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.
Nice To Haves
- Degree in science, engineering, or a related technical discipline.
- Minimum of 3 years of 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.
- Ability to communicate effectively and collaborate across functions and organizational levels.
- Experience leading continuous improvement initiatives to enhance quality system performance and operational effectiveness.
Responsibilities
- 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 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.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
