Quality Assurance Specialist jobs in Fremont, CA

Pulmonx is looking for a Quality Assurance Specialist II 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:

• Perform all activities related to Device History Records review and product release activities.
• Perform administrative activities related to Correction, CAPA and Deviations and perform effectiveness checks as needed.
• Effectively maintain QA/QS related LOGS (Supplier Logs, Internal Audits, CAPA, and EM logs, cleaning logs, complaints logs etc…).
• Perform Sterile Load processing, review, and sterility release activities.
• Provide oversight of routine Cleanroom Microbiological Environmental Monitoring (EM) program, Cleanroom cleaning schedule, and pest control monitoring activities, and review reports.
• Support cross-functional investigations related to EM excursions / adverse trends.
• Manage Training of Suppliers, contractors, and consultants
• Maintain the approved supplier list and supplier audit schedule.
• Assist in identifying continuous improvement opportunities.
• Provide support with internal and regulatory audits/inspections as required and other QA/QS related tasks.
• Support company goals and objectives, policies and procedures, ISO/MDD/MDR requirements, the Quality System Regulation, and other regulatory requirements
• Perform other duties as assigned

Requirements:

• Bachelor’s Degree in a scientific discipline or equivalent work experience required
• Minimum of 2 years’ experience in Quality Assurance, Quality Control, or a GMP related field within a medical device facility required
• Minimum 2 years related experience performing lot release in the medical device industry desired.
• Working knowledge of FDA’s Quality Systems Requirements (QSR) and ISO 13485, MDD/MDR requirements.
• Knowledge of Microbiological Environmental monitoring is preferred.
• Strong knowledge of Good Documentation Practices
• Knowledge of CAPA and deviations processes.

Compensation: $80,000 - $95,000/year 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.

#LI-Post #LI-Onsite