- Bristol Myers Squibb (Devens, MA)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary:** The Quality Assurance Shop Floor team is responsible for 24x7 Quality ... and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. This position works a Monday to… more
- Bristol Myers Squibb (Devens, MA)
- …BMS with our Cell Therapy team. This is a key role on the Shop Floor Quality Assurance team. As **Manager, Shop Floor Quality Assurance, Cell Therapy** , you ... lead a team of 4-8 employees. The Shop Floor Quality Assurance team is responsible for 24x7 Quality...to research, understand, interpret, and apply internal policies and regulatory guidelines + Proficient computer skills with knowledge of… more
- Hologic (Marlborough, MA)
- …love to have you on our team! **Knowledge:** + Strong understanding of FDA Quality System Regulations, particularly Design Control requirements. + In-depth ... + Detail-oriented and committed to maintaining the highest standards of quality and regulatory compliance. + Proactive and decisive, with the ability to… more
- Oracle (Boston, MA)
- …Cloud SCM, Manufacturing, Quality , and ERP** integrations. + Knowledge of ** regulatory compliance processes** ( FDA , ISO, cGMP) and quality documentation ... initiatives, spanning **Innovation Management, Product Development, Product Hub, and Quality ** modules. You'll collaborate with cross-functional business teams (Manufacturing,… more
- North Coast Seafoods (Boston, MA)
- …contact between the production staff and the Quality department for all Quality , Food Safety and Regulatory issues + Responsible for filling out assigned ... The Quality Control Technician is responsible for testing seafood...motions: bending, twisting, squatting and reaching + Exposure to FDA approved cleaning chemicals + Exposure to temperatures: <32… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …planning of regulatory interactions and Provides tables and listings for FDA meeting briefing packages. + Support statistical needs for market access and ... statistical expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is a strategic and critical role in… more
- Oracle (Boston, MA)
- …designs are aligned with device-level safety, performance, and compliance needs. + Regulatory Compliance & Quality Alignment + Ensure adherence to medical ... and IEC 82304 (health software product safety and effectiveness). + Embed regulatory and quality requirements into the architecture and development lifecycle,… more
- Hologic (Marlborough, MA)
- …7 Subpart C (Recalls), 21 CFR Part 806 (Reports of Corrections and Removals), FDA Quality System Regulations, ISO 13485:2016, and EU Medical Device Regulation ... with regulatory requirements and maintaining the highest standards of quality and safety. In this critical role, you'll collaborate cross-functionally with… more
- Abbott (Burlington, MA)
- …teams; and providing information on product complaints to various teams (eg Regulatory , Quality Engineering). **What You'll Work On** *Initiates and manages ... determine if a medical device report needs to be filed with various global regulatory agencies (eg, FDA , European Competent Authorities) and sends reports within… more
- Hologic (Marlborough, MA)
- …implement, and monitor a robust Internal Audit Program, ensuring compliance with FDA regulations, ISO standards, and other global regulatory requirements. If ... patient safety and innovation. **Knowledge** + Deep understanding of FDA Code of Federal Regulations (21 CFR 820), ISO...(eg, ISO 13485:2016, ISO 14971), MDSAP, and other global regulatory requirements. + Expertise in Quality Systems… more