Quality Engineer II
Engineering and other departments. Creates and directs process/equipment validations (IQ, OQ, PQ). Reviews customer contracts...
Engineering and other departments. Creates and directs process/equipment validations (IQ, OQ, PQ). Reviews customer contracts...
), IQ/OQ/PQ documentation, and regulated environments. Familiarity with Agile/Scrum development methodologies...
/OQ/PQ Process Validations. Perform Test Method Validation (Gauge R&R) and Software Validation. Manage BOMs and product.... Experience with: Process Validation (IQ/OQ/PQ) Test Method Validation (Gauge R&R) PLM Systems ERP/MRP Systems Statistical...
), IQ/OQ/PQ documentation, and regulated environments. Familiarity with Agile/Scrum development methodologies...
/PQ), ensuring instruments meet audit trail, system control, and data integrity requirements. Strengthen OOS/OOT...
-specific job aids (including Temenos, L360, Meridian Link, Correlation Keystone, Loans PQ, and Ideal) that are accessible... with Temenos, L360, Meridian Link, Correlation Keystone, Loans PQ, or Ideal strongly preferred. Knowledge of indirect auto lending...
(PQ) on new equipment, new products and existing product changes for tooling design and development;execute Test Method...: Extrusion process and project engineering;ISO 9001, ISO 13485, and cGMP;DOE, SPC, FMEA, QSR, IQ/OQ/PQ, and technical writing...
documentation, including work instructions, validation protocols (IQ, OQ, PQ), and standard operating procedures (SOPs). Ensure...
(IQ/OQ/PQ), quality design reviews deliverables, risk management plan, and all quality related documentation. Assist...
studies (IQ, OQ, PQ) and contribute to process control improvements. Assist in root cause analysis, CAPA (Corrective... knowledge of process validation, including IQ, OQ, and PQ requirements. Exposure to PFMEA and risk assessment tools related...