Job-ID32575114Reference26-01229Remote50% Remote Responsibilities: Develop and execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols specifically for blood glucose monitoring sensor manufacturing equipment. Define and document critical process parameters (CPPs) and equipment capabilities to ensure stable sensor performance within specification limits. Establish preventive maintenance plans, calibration schedules, and critical spare parts lists. Author validation plans, validation protocols, test reports, including deviations and corrective actions and Standard Operating Procedures (SOPs). Utilize tools such as Minitab to analyze large datasets from sensor builds, performing Design of Experiments (DOE) and process capability studies. Perform equipment risk assessments, including pFMEA and hazard analysis. Define User Requirements Specifications (URS) for new equipment and lead equipment installation and commissioning efforts. Train technicians and operators on validated equipment procedures. Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP regulations. Partner with R&D, Quality Assurance, and external vendors to scale up pilot lines to high‐volume production. Work with Manufacturing Engineers to improve equipment reliability and throughput. Support internal and external audits by providing equipment validation evidence. Requirements: Bachelor's degree in mechanical, Electrical, Industrial, Biomedical Engineering, or a related field. 3+ years of equipment validation experience within medical device manufacturing. Strong understanding of GMP, GAMP 5, and FDA equipment validation requirements. Familiarity with automated equipment, robotics, PLCs, and machine vision systems. Preferred Qualifications: Prior experience validating equipment for biosensor or electrochemical sensor manufacturing, or experience in the semiconductor industry for wafer production. Experience with high‐speed automation and semi‐automated production lines. Certification in equipment validation or GAMP 5 training.
...be working with Patient Access teams. They will be working on Prelude, RTE, Referrals, Hello World and Cadence support Working on Epic Cadence/Prelude configuration changes and build by maintaining industry and client standards ensuring build quality and timeline...
Provincial Senior LivingProvincial Senior Living, proudly part of the Discovery Senior Living family of operating companies, manages lifestyle-focused senior living communities. Our company, which was built on our "Pillars of Excellence," employs thousands of vital Team...
...to read a room, handle questions on the spot and keep people coming back. Those skills translate directly into this role. As a Business Associate you will work on-site in Oakbrook Terrace with a team focused on helping clients review and understand their benefit options...
A multimedia company is seeking an intern for a 3-6 month paid videography internship in Washington, DC. Interns will learn about videography... ...events and creative content. Ideal candidates should have basic video skills, a passion for working with people, and a desire to grow...
...Job Description: A Patient Access Registration Specialist I is responsible for providing excellent customer service and facilitating the registration and scheduling process for patients and visitors at Intermountain Health. The caregiver ensures that accurate and complete...