Join the Pulmonx team as a Quality Assurance Technician II and be part of a dynamic group dedicated to improving lives across the US. Thisopportunity offers you an exciting opportunity to collaborate with an exceptional team. If you're seeking a role that combines meaning and purpose, this is your chance to contribute to the cause of helping people breathe better!
Hours: 1:30pm - 10:00pm
Compensation: $30 - $37 per hour DOE + 15% shift differential
Location: On-site at our Corporate Offices 700 Chesapeake Drive, Redwood City, CA
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.
Execute written protocols, gather data, and generate basic reports.
Assist in identifying continuous improvement opportunities.
Maintain compliance with Pulmonx Quality Management System.
Decontaminate and aid in product analysis of returned complaint devices as assigned.
Requirements:
High school diploma or equivalent required. Associate's degree or equivalent industry experience preferred.
Minimum of 3 years of experience performing QA inspections/testing activities pertaining to IQA, in-process, lot release, DVT, and process validations in the medical device industry required.
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.
Please note that an application and resume must be completed and submitted for consideration for this opportunity.
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.