- Fresenius Medical Center (Lawrence, MA)
- …are compliant with internal and external standards, good manufacturing practices, and quality system regulations **Requirements:** * Candidate for BS or MS in ... desired * Prior relevant work experience is preferred, such as working in an FDA , defense industry or ISO regulated environment * Understanding of aspects of system… more
- Edwards Lifesciences (Boston, MA)
- …also advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind. + Leading ... developing case report forms and clinical database to ensure quality data collection + Leading the efforts of data...+ Proven expertise in SAS + Experience using other software packages (eg, R, S-Plus) + Extensive understanding and… more
- Philips (Cambridge, MA)
- …Manager will play a critical role within Philips Patient Safety & Quality Organization, responsible for enhancing tracking and controlling systems to optimize ... and timely tracking of regulatory activities and ensures validation of regulatory affairs software tools. **You're the right fit if:** + You've acquired a minimum of… more
- Mentor Technical Group (Boston, MA)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... Management (LCAM) Program at sites according to corporate standards. + Ensure quality work execution and maintain technical excellence. + Engage and collaborate with… more
- Catalent Pharma Solutions (Chelsea, MA)
- …Chelsea MA facility. Support spray drying and downstream operations by providing quality , compliant and timely equipment service to prevent excessive down-time and ... committed to a Patient First culture through excellence in quality and compliance, and to the safety of every...in cGMP biopharmaceutical; pharmaceutical, medical device, food, or other FDA regulated industry; + Basic to moderate computer skills… more
- Fujifilm (Boston, MA)
- …and providing our customers with timely responses. + Works on 3rd party hardware, software , and network related issues that are sold or supported by FUJIFILM. + ... the business, to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job… more
- Schrodinger (Cambridge, MA)
- …to join us in our mission to improve human health and quality of life through the development, distribution, and application of advanced computational ... target classes and therapeutic areas. We're supported by more than 100 software developers and engineers, as well as a large-scale computational infrastructure to… more
- Sanofi Group (Cambridge, MA)
- …in design controls and FDA / ISO 13485 / IEC 62304 compliant software development, regulatory submissions, and launch is preferred. + Having knowledge of EHR and ... family, with a wide range of health and wellbeing benefits including high- quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral… more
- Fujifilm (Boston, MA)
- …and providing our customers with timely responses. + Works on 3rd party hardware, software , and network related issues that are sold or supported by FUJIFILM. + ... the business, to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job… more
- Veterans Affairs, Veterans Health Administration (West Roxbury, MA)
- …and senior staff. Ensures surgical implants are Federal Drug Administration ( FDA ) approved/cleared; collaborates with Supply Chain Management to establish local ... basic knowledge of inventory management procedures; ability to use computer software packages for word processing, spreadsheet development, and database management;… more
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