Quality Engineering Manager
4 weeks ago
The Quality Engineering Manager will lead the Quality Assurance manufacturing team in Boston, MA, ensuring continuity across all manufacturing sites. This role directs quality personnel working with manufacturing and IVD operations teams within the Quality System Program, including manufacturing process review, batch release of products, IVD assay validation and verification, manufacturing material acceptance, device non-conformance and CAPA investigation.
Key Responsibilities- Lead teams participating in the development and approval of design and development documents, quality system procedures, and manufacturing documentation and controls.
- Subject matter expert and strategist for audit-related questions within their subject matter area and beyond, including front room and back room support and management for FDA, Notified Body, or pharma partners.
- Ensure all activities are conducted in compliance with the FMI Quality Management System, appropriate regulations, international and national regulations and are aligned with regulatory agency expectations.
- Direct programs or procedures which assure the proper compliant manufacturing, the timely data analysis and reporting of trends and the completion of written investigations in response to unusual or unexpected results or deviations.
- Perform manufacturing batch and manufacturing material review and release.
- Assist with the expansion of the manufacturing program in compliance with IVDR, ISO 13485, and pertinent regulatory bodies.
- Effectively collaborate with a fully integrated team to facilitate the completion of documents.
- Lead Root Cause Analysis (RCA), Design of Experiments (DOE), Corrective and Preventative Action (CAPA), LEAN, and similar continuous improvement initiatives with a solution-focused mindset.
- Maintain Quality Management Systems for functional areas including Design Controls, Production and Process Controls, Software Development, Risk Management, Corrective and Preventative Action (CAPA) system and Non-Conforming Material Reports.
- Conduct root cause analysis and implementation of correction, corrective and preventative actions, and verification of effectiveness of actions as periodically required in the identification and resolution of issues.
- Guide the organization on strategy and implementation of continuous improvement of the quality system.
- Management of quality professionals, including ensuring activities are completed aligned with goals and continuous personnel development.
- Provides training and mentorship to less experienced members of QA staff across the QA organization.
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Quality Engineering Manager
4 weeks ago
Étreux, Hauts-de-France, United States Foundation Medicine Full timeAbout the JobThe Manager, Manufacturing Quality Engineering in the Quality Assurance department is a key and critical role at Foundation Medicine. This role presents the incumbent with an opportunity to lead various teams within the organization.Key Responsibilities:Lead teams participating in the development and approval of design and development documents,...
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FedNow Manager, Quality Engineering Lead
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Étreux, Hauts-de-France, United States Federal Reserve Bank (NY) Full timeFedNow Manager, Quality EngineeringJoin the Federal Reserve Bank (NY) team as a FedNow Manager, Quality Engineering, and play a critical role in shaping the future of payments. As a key member of our Quality Engineering team, you will be responsible for leading the development and implementation of quality strategies, test design techniques, and...
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Quality Assurance Engineer
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Senior Design Engineer
4 weeks ago
Étreux, Hauts-de-France, United States Bohler Engineering Full timeOverviewAt Bohler Engineering, we empower professionals to achieve their full potential. Our purpose connects us with like-minded individuals, fosters meaningful relationships, and drives success in the land development consulting and site design services industry.We are seeking a Senior Design Engineer who embodies this purpose and shares our passion for...
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Quality Assurance Manager
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Étreux, Hauts-de-France, United States Shawmut Full timeOverview:At Shawmut, we pride ourselves on our employee-owned culture, which has earned us over 83 Best Place to Work awards. This includes recognition as a Best Workplace by Fortune Magazine, a Best Workplace for Women, a Best Workplace for Millennials, a Great Place to Work Best Workplace for Parents, and one of America's Best Employers by Forbes.We offer...
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Civil Design Engineer
4 weeks ago
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Facilities Site Engineer
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Étreux, Hauts-de-France, United States Trinity Consultants - Advent Engineering Full timeBiotech Facilities Engineer PositionLocation – BostonTrinity Consultants - Advent Engineering is a leading engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system...
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Facilities Site Engineer
4 weeks ago
Étreux, Hauts-de-France, United States Trinity Consultants - Advent Engineering Full timeJob Title: Facilities Site Engineer - BiotechAt Trinity Consultants - Advent Engineering, we are seeking a highly skilled Facilities Site Engineer to join our team. As a key member of our engineering team, you will be responsible for executing change management for manufacturing equipment and other support systems, managing the creation, revision, and review...
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Senior Design Engineer
3 weeks ago
Étreux, Hauts-de-France, United States Bohler Engineering Full timeOverviewAt Bohler Engineering, we empower professionals to achieve their goals. Our purpose connects us with like-minded individuals, fosters meaningful relationships, and generates alignment necessary for an exceptional consulting and employment experience.Our Boston office is seeking a Senior Design Engineer who embodies this purpose.Key...
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Senior Project Engineer
4 weeks ago
Étreux, Hauts-de-France, United States McClure Engineering Company Full timeJob Title: Senior Project EngineerMcClure Engineering Company is seeking a highly skilled Senior Project Engineer to join our team. As a key member of our development team, you will be responsible for leading complex projects and ensuring their successful delivery.Key Responsibilities:Lead project teams and ensure timely completion of projectsDevelop and...
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Senior Project Engineer
2 weeks ago
Étreux, Hauts-de-France, United States McClure Engineering Company Full timeAbout the Role: We are seeking a highly skilled Senior Project Engineer to join our team at McClure Engineering Company. As a Senior Project Engineer, you will be responsible for leading a variety of high-profile projects and providing technical leadership to our team.Key Responsibilities:Lead project delivery teams by delegating tasks and coaching team...
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Construction Project Manager
4 weeks ago
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Product Manager
4 weeks ago
Étreux, Hauts-de-France, United States Wayfair Full timeProduct Manager - Quality and RecoveryWayfair is seeking a Product Manager to join our Quality and Recovery team. As a Product Manager, you will be responsible for developing and executing product roadmaps that drive business impact and improve the customer experience.Key Responsibilities:Develop a deep understanding of the customer experience related to...
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Package Quality Assurance Manager
2 weeks ago
Étreux, Hauts-de-France, United States Vinci Full timeJob Title: Package Quality Assurance ManagerAt Vinci, we are seeking a skilled Package Quality Assurance Manager to lead the delivery of our high-profile offshore wind turbine generator (WTG) package.Job Summary:Develop and implement comprehensive quality management strategies to ensure the successful execution of the project.Manage integrated site services...
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Electrical Engineering Manager
4 weeks ago
Étreux, Hauts-de-France, United States Massachusetts Bay Transportation Authority Full timeJob SummaryThe Massachusetts Bay Transportation Authority is seeking a highly skilled Electrical Engineering Manager to join our team. As a key member of our Engineering Department, you will be responsible for establishing electrical and power standards, managing electrical and power quality, and developing capital improvement projects for our power and...
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Senior Manufacturing Engineer
4 weeks ago
Étreux, Hauts-de-France, United States Motion Recruitment Partners LLC Full timeJob SummaryWe are seeking a highly experienced Senior/Principal Manufacturing Engineer with a strong focus on Quality Engineering to join our team. As a key member of our quality engineering team, you will be responsible for shaping and maintaining the quality standards of our advanced robotic systems throughout the manufacturing lifecycle.Key...
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Étreux, Hauts-de-France, United States Massachusetts Bay Transportation Authority Full timeJob SummaryThe Massachusetts Bay Transportation Authority is seeking a highly skilled Deputy Director of Infrastructure Maintenance Quality Management to join our team. As a key member of our Engineering and Maintenance Department, you will be responsible for establishing and interpreting department policies and procedures, creating and revising...
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Software Quality Assurance Engineer
4 weeks ago
Étreux, Hauts-de-France, United States Jobot Full timeJob SummaryWe are seeking a skilled Software Engineer in Test to join our team. The ideal candidate will have experience with Go, Python, and React testing, as well as a passion for creating and maintaining stable software applications.Key ResponsibilitiesDesign, develop, and execute automation scripts using open source tools.Identify, record, document...
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Electrical Engineering Manager
4 weeks ago
Étreux, Hauts-de-France, United States Massachusetts Bay Transportation Authority Full timeJob SummaryThe Massachusetts Bay Transportation Authority (MBTA) is seeking a highly skilled Electrical Engineering Manager to join our team. As a key member of our Engineering and Maintenance department, you will be responsible for establishing electrical and power standards, coordinating with other departments and outside agencies, and providing complex...
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Quality Management Specialist
4 weeks ago
Étreux, Hauts-de-France, United States Consigli Construction Full timeQuality ManagerConsigli Construction Co., Inc. is seeking a highly skilled Quality Manager to join our team. As a Quality Manager, you will play a critical role in ensuring the highest quality standards are met on our construction projects.Key Responsibilities:Develop and implement quality management plans for assigned projectsOversee project teams'...