- Philips (Cambridge, MA)
- ** Senior CAPA Engineer ** **In this role you** The Senior CAPA Engineer is responsible for driving CAPA activities from issue identification ... to closure, effectively project managing all CAPA activities, ensuring the quality of CAPA record content and representing CAPAs during audits and CAPA … more
- Integra LifeSciences (Boston, MA)
- …pathways to advance patient outcomes and set new standards of care. The Senior Manufacturing Engineer will lead and support engineering projects and operations ... and regulatory compliance, in a medical devices regulated industry. The Senior Manufacturing Engineer will be responsible for identifying opportunities… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Senior Quality Engineer , Contamination Control **Location** : Framingham, MA **About the Job** We deliver 4.3 billion healthcare solutions to ... management reviews. + Investigate and assess EM/CU excursions and determine appropriate CAPA . + Provide trending for EM, and critical utilities monitoring in an… more
- Integra LifeSciences (Boston, MA)
- …set new standards of care. This position is for a Sr. Supplier Quality Engineer l - Global Supplier Quality with hands-on experience and proven success in managing ... eQMS, risk assessment, process qualification, process controls, root cause investigations, CAPA , and continuous improvement + Provide support to sites by leading… more
- Sanofi Group (Framingham, MA)
- **Job Title** : Senior Manufacturing Compliance Engineer **Location:** Framingham, MA **About the Job** We deliver 4.3 billion healthcare solutions to people ... training program, and identifying and managing continuous improvement initiatives. Senior Manufacturing Compliance Engineer uses expert knowledge of… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Senior Quality Engineer , QMS **Location** : Framingham, MA **About the Job** We deliver 4.3 billion healthcare solutions to people every year, ... meet regulations and drive continuous improvements. As a key user of the CAPA , Deviation, and Investigation (CDI) QMS, you'll oversee system health, be the quality… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Senior Compliance Engineer **Location** : Framingham, MA or Northborough, MA **About the Job** We deliver 4.3 billion healthcare solutions to ... regulations and guidance. * Demonstrated experience with Change Control, CAPA and deviation quality systems. **Preferred Qualifications:** * Technical experience… more
- Integra LifeSciences (Boston, MA)
- …treatment pathways to advance patient outcomes and set new standards of care. The Senior Quality Engineer II is responsible for providing quality and engineering ... into the facility. Leading investigational activities around non-conformances and CAPA 's. Works collaboratively with Manufacturing, Engineering, Quality Assurance, and… more
- Tecomet (Woburn, MA)
- **POSITION SUMMARY** The Supplier Quality Engineer is responsible for managing supplier quality, and leading the CAPA program for supplier non-conformances. ... Coordinates and drives improvements in quality, cost, and delivery. Extensive knowledge of quality system requirements ISO 13485 & CFR 820. Relies on experience and judgment to plan and accomplish goals. Works independently with minimal supervision.… more
- Globus Medical, Inc. (Methuen, MA)
- …as quickly as possible. **Position Summary:** The Continuous Improvement Engineer will spearhead process optimization, efficiency enhancement, and operational ... proactively updating leadership on project progress. + Participate in internal audits, CAPA processes, and root cause analysis to ensure regulatory compliance. +… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Principal Quality Engineer - Quality Assurance Contamination Control **Location** : Framingham, MA **About the Job** We deliver 4.3 billion healthcare ... CC site lead, Quality Assurance, the Environmental Action Committee (EAC) and senior leadership. + Actively support work plans with other contamination control teams… more
- Amazon (Westborough, MA)
- …for a Co-op assignment. The candidate will have the opportunity work with senior engineering staff on existing and new and existing tools, mechanisms, modules and ... can potentially handle multiple parallel tasks. This position reports to a Hardware Development Engineer on the Amazon Robotics team. This role is a 6 month co-op to… more
- Astellas Pharma (Westborough, MA)
- …+ Fluency in Deviation investigation techniques, root cause analysis methods, CAPA effectiveness verification, and product impact assessments. + Working fluency in ... data tables and PowerPoint). + Comfort presenting data, facilitating meetings with senior stakeholders, and maintaining minutes of key decisions and outcomes. +… more
- Astellas Pharma (Westborough, MA)
- …reporting. + Assists with the Deviation and Corrective / Preventive Action ( CAPA ) programs, aids investigations, and may assume investigation leader status for ... satisfy new compliance requirements or improve work practices. + May assist senior QA staff in oversight of contract manufacturing organizations (CMO), monitoring… more
- Astellas Pharma (Westborough, MA)
- …reporting. + Assists with the Deviation and Corrective / Preventive Action ( CAPA ) programs, aids investigations, and may assume investigation leader status for ... satisfy new compliance requirements or improve work practices. + May assist senior QA staff in oversight of contract manufacturing organizations (CMO), monitoring… more