- J&J Family of Companies (Danvers, MA)
- …lifecycle (Agile/waterfall/SAFe/DevOps) by defining the requirements, design, verification and validation plan and strategies while maintaining traceability. + Use ... + Ensure that Design Controls are compliant with IEC 62304. + Ensure that FDA and other regulatory knowledge and experience is applied to risk management, software… more
- Actalent (Springfield, MA)
- …the implementation of the Food Safety Plan and ensuring compliance with all applicable FDA regulations (21 CFR 111 and 117). Additionally, you will manage the site ... programs for GMPs, HACCP/Food Safety, and Food Defense + Manage validation and verification activities, including sanitation validation , internal inspections,… more
- Bristol Myers Squibb (Devens, MA)
- …up to operator interfaces and databases. + Work in collaboration with Validation , Quality and Manufacturing Engineering and Manufacturing operations to keep the ... on OSI PI data historian applications is preferable. + Experience on automation validation (DeltaV, MES, PI) in GMP environment that includes test script generation… more
- J&J Family of Companies (Danvers, MA)
- …& Development:** + Lead and execute detailed engineering design, testing, and validation activities for existing and new products. + Develop and refine product ... regulatory requirements and internal quality standards. + Support documentation, validation , and verification activities to maintain compliance **Process Optimization… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …test requirements, development of test plans, hardware and software design, assembly, debug, validation and release of test equipment for use both at ZOLL Medical ... & Fixtures + Test Strategy & Requirements Development Test Plan Development + Validation Plan Development Documentation of Test Systems & Fixtures Test System Debug… more
- Sumitomo Pharma (Boston, MA)
- …warehouse environment. + Ensure that all SAP solutions adhere to **GXP, FDA , and other regulatory requirements** applicable to the pharmaceutical industry, including ... validation and documentation standards. **Team Management & Governance** +...Medical Device)** , with a clear understanding of GXP, validation , and compliance requirements. + Proven track record of… more
- J&J Family of Companies (Danvers, MA)
- …investigations, non-conformance handling, and ERP systems. + Experience developing process validation plans, including IQ/OQ/PQ protocols and reports. + Knowledge of ... systems/optical comparators to aid in information discovery. **Preferred:** + Knowledge of FDA 21CFR820/821 and ISO 13485 requirements. + Previous use of SAP, MS… more
- Abbott (Burlington, MA)
- …Harms, and severity and probability assessments + Develop and lead clinical validation plans and activities, ensuring robust evidence for product performance and ... safety. + Contribute to the evaluation and validation of a specific subsystem, system, or product prior to submission + Support all company initiatives as identified… more
- Fujifilm (Boston, MA)
- …technical aspects of Synapse product HL7 integration, from install, configure and validation phases through product go-live, for all Synapse MI products. HL7 IE's ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Philips (Cambridge, MA)
- …project management, business analysis, service management, solution ownership, and validation to achieve targeted outcomes. + Promotes application standardization ... experience in Medical Device Clinical Research and Medical Device development within FDA regulated OEM product environments. + You have proven experience in clinical… more