Quality Technician (Swing)

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

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.