Quality Technician (Swing)

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

• Location 700 Chesapeake Drive,Redwood City, CA, 94063,United States
• Base Pay $32.00 - $40.00 / Hour
• Average Bonus $5.00
• Employee Type Employee

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.

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.