Quality Technician - Medical Device QA & IQA

Kids for the Future; Redwood City (CA); On-site; USD 44,000 - 55,000; Full time

Job summary

Pulmonx Corporation in Redwood City, CA is seeking an experienced QA Inspector to perform inspections and testing of IQA, in-process, lot release, DVT, and process validations in the medical device field.

You will generate detailed inspection reports, maintain QA logs, train Level I–II technicians, and help implement continuous improvements while ensuring compliance with ISO13485 and FDA QSR/cGMP requirements.

Qualifications

• Associate’s degree or equivalent industry experience preferred.
• Certified Quality Technician (CQT) or CQIA preferred.
• Minimum 5 years QA inspections/testing for IQA, in-process, lot release, DVT and process validations in medical devices.
• Strong understanding of ISO13485 / FDA QSR/cGMP requirements.
• Ability to read technical specifications and mechanical drawings.
• Experience with MS Office and ERP systems.
• Good written and verbal communication skills.

Responsibilities

• Perform inspections/testing of IQA, in-process, lot release, DVT, and process validations.
• Generate inspection/testing reports per cGMP and maintain files.
• Generate MRRs and related inspection activities.
• Maintain QA logs/databases (IQC, MRR, RGA, PER).
• Train QA technicians Level I-II in inspection, testing and Quality Systems.
• Inspect returned product for packaging integrity.
• Collaborate with QE, ME and R&D on test procedures.
• Execute protocols, gather data and generate reports.
• Identify continuous improvement opportunities.
• Maintain compliance with Pulmonx QMS.
• Decontaminate and aid in product analysis of returned devices.
• Calibrate equipment and product as assigned.

Skills

Communication skills

Reading technical specs

Mechanical drawings

QA inspections

Education

Associate degree

Tools

MS Word

MS Excel

MS Access

ERP

Job description

Pulmonx Corporation in Redwood City, CA is seeking an experienced QA Inspector to perform inspections and testing of IQA, in-process, lot release, DVT, and process validations in the medical device field.

You will generate detailed inspection reports, maintain QA logs, train Level I–II technicians, and help implement continuous improvements while ensuring compliance with ISO13485 and FDA QSR/cGMP requirements.