Quality Engineer I

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

Job Description

Job Description

About INOVIO

INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO’s technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit www.inovio.com.

Job Summary

The Quality Engineer I supports the implementation and maintenance of FDA and ISO 13485:2016 compliant Quality Systems within an electro-mechanical medical device manufacturing environment, including Class 7/8 Cleanroom operations for manufacturing sterilized/disposable products. This role assists in managing the environmental monitoring system, including documenting alerts, supporting required responses and preparing trending data and reports for management. The Quality Engineer I also supports activities related to sterilization release records, investigations and resolution of non-conformances, environmental monitoring excursions, equipment calibrations and preventive maintenance, and action items associated with corrective actions.

Essential job functions and duties

• Manage the QMS environmental monitoring system, including response and documentation of alert notifications (e.g., Vaisala).
• Provide quality engineering support and guidance for cleanroom environmental operations to ensure compliance with applicable requirements.
• Document, manage, and drive investigations and resolutions related to environmental monitoring excursions.
• Assist with equipment management activities, including calibration and preventive maintenance coordination.
• Prepare and report environmental excursion data and trending analyses to management to support process improvements.
• Collaborate with other departments as needed to assist with investigations and continuous improvement activities.
• Assist with documentation associated with product sterilization activities.
• Support additional Quality Assurance/Quality Control projects and tasks as assigned.

Minimum requirements

• Bachelor’s degree in engineering or a related field preferred, or equivalent combinations of education and experience.
• 1 -2 years of experience in medical device, biotech, or regulated industry.
• Ability to present verbal and written information, trends, and investigation results to cross-functional teams and management.
• Proficiency in Microsoft Word, Excel and Outlook, Visio, PowerPoint software applications.
• Capable of preparing technical reports, business correspondence, etc.
• Ability to understand engineering drawings, specifications, diagrams, schedules, and written instructions.
• Proven ability to plan, prioritize, and complete technical assignments with limited supervision. Able to perform varied tasks consistently and maintain clear communication across teams. Familiarity with statistical controls and data analysis tools is a plus.

Disclaimer

INOVIO Pharmaceuticals, Inc. is an Equal Employment Opportunity Employer, including but not limited to veterans and individuals with disabilities. We prohibit discrimination of any kind. In keeping with our policy, we recruit, hire, train, and promote the most qualified individuals for all job titles, and we provide equal opportunities to all employees and applicants for employment.

A current US work authorization is required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. INOVIO offers an attractive benefits package and is an equal opportunity employer.

Important notice to employment businesses/agencies

INOVIO does not accept referrals from employment agencies unless written authorization from the INOVIO Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore INOVIO will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at INOVIO.