Medical Device QA Technician - IQA & Process Validation

Pulmonx Corporation; Redwood City (CA); On-site; USD 44,000 - 55,000; Full time

Benefits offered by this job

Shift differential 15%

Job summary

Pulmonx Corporation is seeking a QA Inspector to perform inspections and testing of IQA, in-process, and finished goods, contributing to lot release and V&V. You will generate detailed reports, maintain QA logs, and support MRR workflows in a cGMP environment.

Candidate should have at least 5 years of QA inspection experience in medical devices, understanding ISO13485 and FDA QSR/cGMP requirements, and be proficient with Microsoft Office and ERP systems.

Qualifications

• Associate’s degree or equivalent industry experience 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.

Responsibilities

• 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.

Skills

QA inspections

CQT/CQIA

Quality systems

Technical drawings

MS Word

MS Excel

MS Access

ERP

Education

Associate degree

Tools

MS Word

MS Excel

MS Access

ERP

Job description

Pulmonx Corporation is seeking a QA Inspector to perform inspections and testing of IQA, in-process, and finished goods, contributing to lot release and V&V. You will generate detailed reports, maintain QA logs, and support MRR workflows in a cGMP environment.

Candidate should have at least 5 years of QA inspection experience in medical devices, understanding ISO13485 and FDA QSR/cGMP requirements, and be proficient with Microsoft Office and ERP systems.