- Bristol Myers Squibb (Devens, MA)
- …records. + Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Performing ... tasks in a manner consistent with the safety policies, quality systems , and GMP requirements. + Completing training assignments to ensure the necessary technical… more
- Medtronic (Danvers, MA)
- …include (but are not limited to):** + Contribute towards process design, validation , and scale-up of new and existing injection molding operations supporting complex ... PFMEAs, control plans, and work instructions in compliance with FDA and ISO 13485 standards. + Partner with external...The employee is also required to interact with a computer , and communicate with peers and co-workers. Contact your… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Affairs' efforts in creating submission materials for various regulatory domains including FDA , PMDA, and EU-MDR. **Job Duties** + Advise SW development teams on ... and activities for the inclusion of ML/AI development, cloud infrastructure, and validation best practices. + Collaborate on the update of SDLC and operations… more