Quality Engineer I — Medical Device Cleanroom Specialist

INOVIO PHARMACEUTICALS INC; California; On-site; USD 72,000 - 90,000; Full time

Job summary

INOVIO Pharmaceuticals, Inc. is seeking a Quality Engineer I to support FDA and ISO 13485:2016 quality systems in an electro-mechanical medical device setting, including cleanroom operations. You will help manage environmental monitoring, documentation, and trending for management review.

The role requires a BS in engineering or related field, 1–2 years in a regulated industry, and strong MS Office skills. You will collaborate across functions to drive continuous improvement and ensure product

Qualifications

• Bachelor’s degree in engineering or a related field, or equivalent.
• 1–2 years of experience in medical device, biotech, or regulated industry.
• Proficiency in Microsoft Word, Excel and Outlook, Visio, PowerPoint.
• Ability to present verbal and written information, trends, and investigation results to cross-functional teams and management.
• Ability to understand engineering drawings, specifications, diagrams, schedules, and written instructions.
• Familiarity with statistical controls and data analysis tools is a plus.

Responsibilities

• Manage the QMS environmental monitoring system and document alerts.
• Provide quality engineering support for cleanroom environmental operations.
• Investigate environmental monitoring excursions and drive resolutions.
• Assist with equipment management, calibration, and preventive maintenance.
• Prepare environmental excursion data and trending analyses for management.

Skills

Verbal and written communication

Cross-functional collaboration

Problem-solving

Education

Bachelor's degree in engineering or related field

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Visio

Job description

INOVIO Pharmaceuticals, Inc. is seeking a Quality Engineer I to support FDA and ISO 13485:2016 quality systems in an electro-mechanical medical device setting, including cleanroom operations. You will help manage environmental monitoring, documentation, and trending for management review.

The role requires a BS in engineering or related field, 1–2 years in a regulated industry, and strong MS Office skills. You will collaborate across functions to drive continuous improvement and ensure product