- GRAIL (Durham, NC)
- …Assist the Quality Systems Software Business Owner/SME with validation and configuration maintenance/improvements, including testing for system ... power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's… more
- System One (Park Ridge, NJ)
- …+ Sterilization & Microbiological Expertise + Lead development, optimization, and validation of sterilization processes including ethylene oxide, dry heat, gamma ... Leadership & Scientific Rigor + Oversee microbiological method development, validation , and data interpretation for regulatory submissions + Manage complex… more
- BeOne Medicines (Pennington, NJ)
- …and release of material, intermediates and finished products under FDA /EU regulations, applicable International Regulations, BeOne processes and procedures. ... late phase activities. + Oversee QC Biochemistry laboratory related quality systems to ensure conformance with regulations and BeOne Global quality standards.… more
- Abbott (San Diego, CA)
- …role oversees the design, development, and validation of software for embedded systems , ensuring compliance with FDA requirements. They play a crucial role ... problems of moderate scope. Participate in software development, verification, and validation activities under guidance Adhere to FDA -compliant Design Control… more
- BD (Becton, Dickinson and Company) (Cayey, PR)
- …manner. + Responsible in hiring, training, and supervising of documentation systems personnel, validation personnel, validation contractors, and ... Summary** This position reports to the Sr. Quality Manager. The Quality Systems Manager is responsible for providing Quality and technical leadership and supervision… more
- Bristol Myers Squibb (Summit, NJ)
- …no better place than here at BMS with our Cell Therapy team. The **Lead Computer System Validation (CSV) Engineer** supports the successful implementation of ... to the completion of milestones associated with equipment qualification and systems validation . With minimum supervision and given general instructions,… more
- Ultralife Corporation (Newark, NY)
- …products and services ranging from power solutions to communications and electronics systems to customers across the globe in the government & defense, medical, ... Asia, ideally positioned to service global customers. We are looking for a Senior Systems & Test Engineer who will collaborate with NPD groups globally to asses… more
- Terumo Neuro (Aliso Viejo, CA)
- …method validation and data analysis. 3. Demonstrated command and knowledge of FDA and ISO medical device quality system requirements. 4. Proven experience in ... risk assessments and FMEAs. + Lead activities in various Quality Systems such as CAPA, Non-Conformance (NCR), supplier quality, equipment calibration, internal… more
- Medtronic (Fridley, MN)
- …Requirements and System Design to Code Development, Testing, and Validation , ensuring systems meet both technical specifications and regulatory standards ... to lead software and controls integration for automated manufacturing systems . This role requires hands-on experience with Allen-Bradley PLCs,...(eg, FDA , 21 CFR Part 11). You'll work closely with… more
- GRAIL (Durham, NC)
- …control software). + Coordinate preventive maintenance, calibration, and equipment onboarding validation activities, ensuring alignment with **QMS and FDA ... performance and uptime. + Partner with R&D, Software, and Quality teams on system changes, new equipment validation , and controlled rollouts. + Ensure vendor… more
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