- Fresenius Medical Center (Lexington, MA)
- …process awareness + GAMP 5 software validation knowledge + Relevant experience with Quality system IT Platforms - eg Trackwise, Windchill, Agile, IQVIA etc + ... plays a pivotal role in maintaining and enhancing the quality management system (QMS) within the IT ...GMP, ISO 13485) as well as documenting computerized system validation and regulatory requirements (GMQ Annex 11, CFR 21… more
- Fresenius Medical Center (Lexington, MA)
- …Quality Specialists in ensuring the effective implementation and maintenance of the quality management system (QMS) within the IT department. This role ... framework. + Participate in the design and documentation of IT processes and controls, ensuring alignment with quality...GMP, ISO 13485) as well as documenting computerized system validation and regulatory requirements (GMQ Annex 11, CFR 21… more
- Medtronic (Boston, MA)
- …quality such as test design, protocol and results review and other supporting quality evidence. + Consult software tool validation and SOUP analysis + ... standards, including software regulations, risk management, and change control + Ensure all FDA and ISO verification & validation requirements are met and for… more
- Medtronic (Boston, MA)
- …Life** Lead and mentor teams in the development, implementation, and maintenance of quality assurance processes and standards. **Job Title: Quality Engineer II** ... medical technology, services, and solutions, is seeking a highly skilled and experienced Quality Engineer II to join our innovative team. The ideal candidate will… more
- Sanofi Group (Cambridge, MA)
- …Diligence activities. + Review and approve equipment qualification and computer software validation deliverables as Business Quality Representative. + Provide or ... be an integral part of the Sanofi R&D Global Quality Organization entrusted to ensure we our compliant with...studies, raw data, reported results, and facilities comply with FDA , OECD GLP regulations or other health authority guidelines… more
- Allurion (Natick, MA)
- …make a lasting impact on the world. What will you be doing? As our Senior Quality Engineer, you'll play a vital role within our quality assurance team, reporting ... and projects. Your primary focus will be to support the Manufacturing Quality Team by troubleshooting issues, conducting root cause investigations, and providing… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …responsible for requirements management from user needs to verification and validation , system architecture design (including tradeoff decisions), and regulatory and ... among sub-systems. + Collaborate with cross-functional teams, including regulatory, clinical, quality and operations. + Lead development of and maintaining best… more
- Integra LifeSciences (Boston, MA)
- …and adherence to the policies and procedures as they relate to the requirements of FDA Quality System Regulation, ISO 13485 and ISO 9001standards, OSHA and the ... (RCA) and Failure Modes and Effects Analysis (FMEA). + Knowledge of GMPs, FDA guidelines, purchasing practices and process validation . + Must be self-motivated,… more
- Sanofi Group (Cambridge, MA)
- …medical, and regulatory affairs. + Oversee and participate in design validation and verification activities, including developing protocols, conducting validation ... international usability standards and guidance (eg, ANSI/AAMI/IEC 62366-1, ANSI/AAMI HE75, FDA guidance, NMPA guidance, ISO 14971). + Willingness to travel… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …includes: daily manufacturing and test support, process and yield improvement, quality and cost improvements, floor layout, New Product Introduction, process ... Manufacturability (DFM/DFMA), design reviews, BOM structuring, process development, process validation and documentation review. + Manage weekly meeting to review… more
- Medtronic (Boston, MA)
- …scaling, documenting, and executing human factors program activities in accordance with FDA guidance and other relevant international standards (eg, IEC 62366, IEC ... and written communication skills required * Detail-oriented with strong commitment to quality and to the workplace with the ability to efficiently multitask *… more
- Medtronic (Boston, MA)
- …functional group of highly talented software developers, test engineers and quality engineers, collaborating with cross-functional teams to develop and design next ... design, code implementation, unit test, and software and system verification and validation . You will also participate in SAFe/Agile activities including but not… more