Quality Technician (Swing)

Brief Description Perform inspections/ testing activities pertaining to IQA, in-process Subassemblies and Finished Goods, Lot Release and V&V. Generate detailed and accurate inspection and testing reports according to current Good Manufacturing Practices (cGMP), and maintain inspection and testing files. Generate MRRs and complete related inspection activities. Maintain QA related logs and databases (e.g. IQC, MRR, RGA, and PER logs). Assist in training level I - II QA technicians to inspection, testing and Quality Systems processes. Perform inspection of returned product for packaging integrity. Work with QE, ME and R&D Engineers on improving inspection and test procedures. Execute written protocols, gather data and generate basic reports. Assist in identifying continuous improvement opportunities. Implement basic improvements to inspection and test documentation. Maintain compliance with Pulmonx Quality Management System. Decontaminate and aid in product analysis of returned complaint devices as assigned. Perform calibrations of equipment and product as assigned. Responsibilities and Capabilities: Perform inspections/ testing activities pertaining to IQA, in-process Subassemblies and Finished Goods, Lot Release and V&V. Generate detailed and accurate inspection and testing reports according to current Good Manufacturing Practices (cGMP), and maintain inspection and testing files. Generate MRRs and complete related inspection activities. Maintain QA related logs and databases (e.g. IQC, MRR, RGA, and PER logs). Assist in training level I - II QA technicians to inspection, testing and Quality Systems processes. Perform inspection of returned product for packaging integrity. Work with QE, ME and R&D Engineers on improving inspection and test procedures. Execute written protocols, gather data and generate basic reports. Assist in identifying continuous improvement opportunities. Implement basic improvements to inspection and test documentation. Maintain compliance with Pulmonx Quality Management System. Decontaminate and aid in product analysis of returned complaint devices as assigned. Perform calibrations of equipment and product as assigned. Requirements Associate’s degree or equivalent industry experience preferred. Certified Quality Technician (CQT) or Certified Quality Improvement Associate (CQIA) preferred. Minimum of 5 years experience performing QA inspections/testing activities pertaining to IQA, in-process, in-process, lot release, DVT, and process validations in the medical device industry. The ability to understand and follow Quality System Procedures (e.g. SOP and Test Methods). Strong understanding of basic ISO13485 / FDA’s QSR/cGMP requirements. Strong knowledge of a wide variety of inspection and test equipment, and methodologies. Working knowledge in reading and interpreting technical specifications and mechanical drawings. Experience with computer based applications (email, MS Word, MS Access, MS Excel, ERP). Good written and verbal communication skills. Compensation: $32 -$40/hr + 15% shift differential Pulmonx Corporation is an Equal Opportunity Employer and embraces diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any characteristic protected by applicable law. #J-18808-Ljbffr Pulmonx Corporation