Overview
Quality Eng – P3 Jobs in United States at Boston Scientific Corporation
Summary:
This role is responsible for ensuring the organization adheres to the Quality Management System by overseeing quality assurance activities, implementing quality control measures, driving process improvements and identifying areas for improvement. The primary role will be within the Medical business segment, ensuring compliance to US FDA, Health Canada and Latin America regulations. Additional support for the Weighing business and the Technology business will be required to ensure adherence to regulations specific to these industries.
Responsibilities:
Maintain and improve the QMS and own efforts to make updates to the system in compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 9001.
Coordinate cross-functional teams to identify areas of improvement and build consensus on procedures, instructions, job aids, etc.
Conduct internal testing and analysis on defective and/or returned goods to establish root cause for failures.
Support both internal and external audits (FDA, Notified Bodies, Sedex) and drive corrective and preventive actions to address any findings.
Own CAPA and SCARs. Investigate quality trends, perform root cause analysis, and implement corrective and preventive actions.
Lead training efforts to keep the organization aware of any changes to the QMS.
Participate in supplier quality activities such as supplier audits, managing supplier quality agreements, and responding to customer questionnaires.
Maintain control over labeling, including creating and maintaining labeling requirements for various regions in North America.
Support LATAM regulatory needs including obtaining device clearances and design updates to comply with changes to regulations.
Manage complaint analysis and lead meetings to update customers on quality issues and design changes.
Leverage deep understanding of North American regulations to influence the parent company to update their QMS to ensure their design controls are robust and meet current regulatory expectations.
Collaborate with customers to identify root causes of technical issues and implement effective resolutions.
Manage multiple customer issues simultaneously by triaging, prioritizing, and identifying recurring trends to drive efficient resolution and continuous improvement
Provide strong, proactive project leadership by coordinating efforts across teams, ensuring timely follow-ups, and driving issues to resolution.
Identify opportunities for improvement within customer environments and recommend enhancements to equipment, software, processes, or the use of materials and services to optimize performance and efficiency
Necessary Experience and Skills:
Bachelor’s degree or equivalent education and experience sufficient to successfully perform the essential functions of the job may be considered. A Bachelor of Science Degree in Engineering is preferred.
Minimum 5 years of experience in a Quality role within a regulated industry. Medical device industry experience is strongly preferred.
Proficient with Microsoft Office
Strong understanding of ISO 13485, 21 CFR 820, and ISO 9001.
Strong track record of managing all elements of a QMS
Proficient at technical writing and documentation
Ability to manage time, set priorities, and work independently
Strong organizational and project management capabilities
Outstanding written and verbal communication skills
Ability to identify key information and apply a structured approach to problem-solving and root-cause analysis
Strong interpersonal skills with a customer-first mindset
Must be able to work remotely without direct oversight
Willingness to attend off-hour meetings with the parent company located in Japan (typically 2-5 times per month in the evenings)
Willingness to travel occasionally (up to 10%)
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Title: Quality Eng – P3
Company: Boston Scientific Corporation
Location: United States
