- Abbott (San Diego, CA)
- …problems of moderate scope. Participate in software development, verification, and validation activities under guidance Adhere to FDA -compliant Design Control ... for millions of people. This role participates in the design, development, and validation of software for embedded systems, ensuring compliance with FDA … more
- Integra LifeSciences (Princeton, NJ)
- …environment monitoring + Water system monitoring + Bacterial endotoxin test method validation and monitoring + Bioburden test method validation and monitoring ... validation and dose audit management + Ethylene oxide sterilization validation and requalification + Reprocessible device cleaning and sterilization validation… more
- Endo International (Rochester, MI)
- …of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and ... for these areas. Write and review SOPs, test methods, validation protocols and validation reports. The Senior...of information required for the job_ _e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc._ + Has… more
- PCI Pharma Services (Rockford, IL)
- …for planning, developing, implementing and monitoring the equipment and process validation strategy for PCI's Advanced Drug Delivery business. The QE will ... design/tech transfer with NPI by directly supporting or driving validation processes with appropriate risk management leadership. As the...of at least three years of experience in an FDA regulated industry with strong preference to medical device… more
- Fujifilm (College Station, TX)
- …supportfacilities, utilities, and equipment IQ/OQ/PQ or any other validation activity asrequired. + Ensureaccuratedocumentation of maintenance activities such ... are executedeffectivelyand any issues are addressed promptly. + Communicateeffectivelywith Contractors, Validation , Quality Assurance,Quality Control,Operations, Engineers, OEM providers, as well… more
- Colgate-Palmolive (Sanford, ME)
- …21 CFR 210 & 211, and experience in working in a regulated industry (ie FDA ) + Working knowledge of SAP, validation software (KNEAT), InBatch or similar ... internal /external networking. Key technical deliverables include; process optimization and validation , technical transfer including SAP item setup and Management of… more
- Globus Medical, Inc. (Audubon, PA)
- …Sterile Manufacturing Quality. This position ensures compliance with applicable regulatory requirements ( FDA QSR, ISO 13485, EU MDR, MDSAP, etc.) and alignment with ... Engineering + Oversee product quality engineering, including design assurance, process validation , risk management, and post-market feedback. + Ensure robust CAPA,… more
- Medtronic (Fridley, MN)
- …User Requirements and System Design to Code Development, Testing, and Validation , ensuring systems meet both technical specifications and regulatory standards (eg, ... FDA , 21 CFR Part 11). You'll work closely with...with GAMP 5 principles and their application in software validation and documentation is highly desirable. Responsibilities may include… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …in alignment with FDA and QSR standards. + Develop and execute validation plans for service test systems and methods. + AUTOMATION & WORKFLOW IMPROVMENT + ... TestStand, Python, or equivalent frameworks. + Establish test requirements, strategy, and validation approaches for new and existing test methods. + Troubleshoot and… more
- Merck (West Point, PA)
- …of product design and development; manufacturing process development, qualification, and validation ; and design control and risk management techniques to positively ... development programs ranging from concept generation/selection, development, verification, and validation to launch readiness: + Lead the cross-functional Device… more