- Primary responsibility for decontamination and investigation/testing of complaint devices.
- Perform and/or assist Quality Engineers (QE's) in documenting complaint investigation reports and performing risk analysis review.
- Maintain Quality Assurance (QA) related logs and databases (. Complaint and MRR logs).
- Perform MRR and CAPA investigations.
- Execute written protocols and gather data.
- Work with Quality Engineering, Manufacturing Engineering and R&D Engineers on improving inspection and test procedures.
- Assist in calibration of equipment and maintaining equipment control log.
- Assist in development or re-design of inspection and test fixtures.
- Maintain compliance with Pulmonx Quality Management System.
- Perform other Quality System related duties as assigned.
- Associate's degree or equivalent work experience required.
- Minimum of 5 years experience performing QA inspections/testing activities pertaining to IQA, in-process, and lot release in the medical device industry. Medical device complaint investigation experience preferred.
- The ability to understand and follow Quality System Procedures (. SOP and Test Methods)
- Good understanding of basic ISO13485 / FDA's QSR/cGMP requirements.
- Working experience with computer based application programs (email, MS Word, MS Excel, ERP).
- Strong knowledge of a wide variety of inspection and test equipment, and methodologies.
- Working knowledge in reading and interpreting technical specifications and mechanical drawings.
- Good written and verbal communication skills.
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Quality Engineering Technician III - Redwood City, United States - pulmonx
Description
Pulmonx is looking for a Quality Engineering Technician III to join and our team Who is Pulmonx ? We are the maker of the Zephyr Endobronchial Valve and a global leader in interventional pulmonology, planning tools, and treatments for obstructive lung disease.
Responsibilities and Capabilities:
Requirements:
Shift: 5:00 AM – 1:30 PM Monday through Friday
Compensation: $35 - $45/hour dependent upon experience.
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.
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