- Abbott (Scarborough, ME)
- …knowledge of manufacturing equipment and processes. + Leads design of experiments, validation , completion of testing, and analysis of data. Presents data to ... manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, procedures, and other technical documents… more
- Philips (Cambridge, MA)
- …in information technology engineering or computer science. + Strong understanding of FDA validation , ITIL processes, and regulatory compliance. + You must be ... and IT performance optimization projects. + Ensure all solutions comply with FDA validation and regulatory requirements. + Monitor and report on key performance… more
- Lilly (Indianapolis, IN)
- …+ Experience maintaining Computer Systems Validation in line with pharmaceutical computer system quality regulations (eg cGMP's, FDA 21 CFR Part 11) and ... direction and standards. + Experience leading or supporting the Computer System Validation of IT platforms including Data Integrity compliance. + Experience… more
- Teleflex (Olive Branch, MS)
- …on trends. * Process Validations - guide and review protocol development, validation implementation and report review an acceptance; * Quality & Cost Improvement ... compliance with Quality System Regulations and ISO 13485 standards. Experience with FDA and ISO inspections and registration is a plus. * Documentation Control… more
- ABM Industries (Irvine, CA)
- …the development, implementation and effectiveness of Quality Management System per ISO, FDA , and other regulatory agencies. Understands and is aware of the quality ... their area of responsibility, including product design, verification and validation , manufacturing and testing activities. Serve as system administrator, maintain,… more
- Medtronic (Charlotte, NC)
- …exhausted. This activity may include travel to sites to perform both system repair, validation , and data gathering + Validation of warranty claim submissions and ... in the operating room, so healthcare/surgical setting experience + Familiarity with FDA product requirements and regulatory guidelines + Experience with robotics or… more
- BeOne Medicines (Pennington, NJ)
- …and release of materials, intermediates and finished products under FDA /EU regulations, applicable International Regulations, BeOne processes and procedures. ... Physicochemistry laboratory routine operations, including but not limited to validation , SOPs, specifications, testing records, personnel training and assessment,… more
- Edwards Lifesciences (Draper, UT)
- …environment * Experience managing small to medium IT projects * Experience with FDA guidelines for Software Quality and Systems Validation * Proven expertise ... Leadership **What you'll need (Required):** * Bachelor's degree in Computer Science or a related field, and a minimum...in complex global business environment * Prefer experience with FDA guidelines for Software Quality and Systems Validation… more
- Koniag Government Services (Silver Spring, MD)
- …regulatory applications and scientific reports, ensuring accuracy and completeness + Utilize FDA -provided Oracle or Access databases, or other computer systems, ... for data input as required + Perform data validation and quality control functions to maintain data integrity...+ Proficiency in using databases (eg, Oracle, Access) and computer systems for data input and management + Strong… more
- Stryker (San Jose, CA)
- …Analysis (sFMEA), Security Risk Assessments and defect management, software verification/ validation . **Preferred:** + Bachelor's degree in Computer Engineering, ... Medical Division. + Collaborate on software design, development, and validation strategies, ensuring documentation aligns with Quality Management Systems compliance… more