- Medtronic (Northridge, CA)
- …standards for the development and use of medical devices including FDA QSR (Quality Systems Regulations), ISO13485, ISO14971, ISO11135, ISO11737, MDD (Medical Device ... Analysis). Coordinate Design Control, Design Verification and Process Validation. Lead and oversee root cause investigations, ensuring effective coordination and… more
- Takeda Pharmaceuticals (Los Angeles, CA)
- …and/or cost by enhancing microbiological testing and laboratory operations. + Lead and provide project support for QC Microbiology, including microbiological assay ... Standard Operating Procedures (SOP) to ensure compliance with FDA guidelines, QSR , cGMP, and other regulatory standards and drive procedural improvements. +… more
- Sunrise Senior Living (Jackson, NJ)
- …Compliance** + Demonstrate proficiency and understand the Quality Service Review ( QSR ) process and essential quality service standards pertaining to enriching ... excellent quality care and service as measured in the QSR process. + Partner with community team to ensure...may be required per state/provincial regulations + Ability to lead the life enrichment component of the Reminiscence program… more
- J&J Family of Companies (Danvers, MA)
- …traceability and compliance with regulatory and quality systems (eg, ISO 13485, FDA QSR 21 CFR Part 820). **Equipment Selection & Acquisition** + Partner with ... justify, and manage upgrades to improve reliability, throughput, and safety; lead ROI analysis, scoping, and project execution. **Automation & Automated Assembly… more
- Walmart (Hoboken, NJ)
- …not traditionally sold at Walmart (eg, Auto, Financial Services, Travel, QSR , Insurance). Our full-funnel solutions-backed by in-store and online signals-deliver ... Ops) to package solutions, address blockers, and scale "always-on" revenue. Lead responses to RFPs with needs-based proposals aligned to objectives, audiences,… more
- Walmart (Hoboken, NJ)
- …not traditionally sold at Walmart (eg, Auto, Financial Services, Travel, QSR , Insurance). Our full-funnel solutions-backed by in-store and online signals-deliver ... Ops) to package solutions, address blockers, and scale "always-on" revenue. Lead responses to RFPs with needs-based proposals aligned to objectives, audiences,… more
- J&J Family of Companies (Santa Clara, CA)
- …regulatory review. + Oversee daily responsibilities of Complaint Investigation Team + Lead , manage, and develop members of the complaint investigation team within ... + Support company goals and objectives, policies, and procedures, QSR , and FDA regulations. + Other duties as assigned....communication skills + Working knowledge of cGMP, FDA 820 QSR and ISO 13485 or other Quality Systems +… more
- Astrix Technology (Devens, MA)
- …investigations and determine appropriate corrective and preventive actions (CAPA). + Lead , coordinate, and maintain: + Validations across all departments + ... ensure compliance with ISO and FDA Quality System Regulation ( QSR ) standards. + Collect, review, and interpret data for...Strong knowledge of ISO and FDA Quality System Regulations ( QSR ). + Proficiency in MS Office applications (Word, Excel,… more
- Medtronic (North Haven, CT)
- …and international markets including Egypt, LATAM, Europe, and Asia, ensuring compliance with QSR (21 CFR 820), EU MDD/MDR, ISO 13485, and ISO 14971. Position works ... US and international markets including LATAM, Europe, and Asia, ensuring compliance with QSR (21 CFR 820), EU MDD/MDR, ISO 13485, and ISO 14971. **Salary:** $112,000… more
- Medtronic (Jacksonville, FL)
- …disposable equipment; navigate complex regulations including FDA Quality Systems Regulations ( QSR ) 21 CFR 820, ISO13485, ISO14971, and EU Medical Device Directive ... Design and Quality control of Class II and/or Class III medical devices; FDA QSR 21 CFR 820, ISO13485, ISO14971, and EU MDD/MDR; Risk analysis activities including… more