- Hologic (Marlborough, MA)
- …**Experience** + 7+ years of quality engineering experience in the medical device industry, with a focus on electromechanical and IVD devices. ... Manager, Quality Engineering Marlborough, MA, United States We're looking... devices. + Advanced knowledge of electromechanical and IVD medical device standards and best practices. **Skills**… more
- Insight Global (Bedford, MA)
- …Regulatory submissions, complaint systems, and reporting to authorities. - Solid knowledge of medical device regulations (eg, FDA QSR, EU MDR) and standards (eg, ... and documentation meet standards before approval. Support product development and design changes. Handle audit-related quality topics and corrective actions.… more
- Fresenius Medical Center (Lexington, MA)
- …applicable regulations. * Maintains corporate regulatory files including EU technical files/documentation ( Medical Device Directives & Medical Device ... , Inc. products. Will provide regulatory input into key quality system processes such as Design Reviews...of experience as a Regulatory Affairs Specialist in the medical device field or (ii) a Master's… more
- Insight Global (Bedford, MA)
- …process improvements in quality systems. - Knowledge of customer and patient-centered design in medical product development. - Experience writing code or C++ ... management, and design changes. - Strong grasp on Middleware solutions - Medical Device Data management experience - Experience with tools: Jira, ALM, JAMA,… more
- Medtronic (Boston, MA)
- …learn, and a problem solver **About Medtronic:** Together, as one of the largest Medical Device companies in the country, we can change healthcare worldwide. At ... to improve lives of millions. Engineering roles in the Quality engineering group can include Quality , Supplier...and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE)… more
- Takeda Pharmaceuticals (Lexington, MA)
- …the optimization of design control elements to comply with combination produce/ medical device regulations. Lead or assist in deviation, complaint and failure ... and 7+ years preferably within the biopharmaceutical industry or medical device development and commercialization are desired.... design control process evolution to meet device regulations. + Collaborate with Quality , Mfg,… more
- Integra LifeSciences (Braintree, MA)
- …programs to enhance the skills and competencies of employees in a medical device -regulated environment. The Senior Training Specialist will assess training ... and making headway to help improve outcomes. The Senior Quality Compliance Specialist -Training will create and conduct training...field with 5+ years' experience in QA/Compliance within the medical device or similar industry or equivalent… more
- Teradyne (North Reading, MA)
- …powering next-generation technologies through sophisticated solutions. Behind every electronic device you use, Teradyne's test technology ensures your device ... We follow passions for new ideas and strategies. Opportunity Overview: As a Quality Assurance - Automation engineer, you will assess tools to support the software… more
- Teradyne (North Reading, MA)
- …powering next-generation technologies through sophisticated solutions. Behind every electronic device you use, Teradyne's test technology ensures your device ... We follow passions for new ideas and strategies. Opportunity Overview: As a Quality Engineer - Automation engineer, you will assess tools to support the software… more
- J&J Family of Companies (Danvers, MA)
- …experience in Manufacturing, Design or Quality function within in the medical device field + Strong analytical skills, including the ability to assess ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Quality **Job Sub** **Function:** Supplier Quality **Job Category:** Professional… more