Contractor - Quality Engineer II

INOVIO PHARMACEUTICALS INC•San Diego, CA

13h

About The Position

The Temporary Quality Engineer II provides hands-on quality engineering and quality systems support for product development and pilot manufacturing activities. This position supports a variety of assigned quality projects, including document creation and updates, change control support, record review, and follow-up on action items. This role will assist with implementation and maintenance of quality processes related to design changes, process changes, documentation updates, quality metrics, management review support, and general quality system compliance activities. The temporary Quality Engineer II will work cross-functionally with Engineering, Manufacturing, Quality Control, and other functions to help ensure that quality records are complete, accurate, timely, and compliant. This role requires strong attention to detail, solid organizational skills, technical capability, and the ability to work effectively in a fast-paced environment with shifting priorities. This position requires flexibility and willingness to support both technical and routine quality tasks as needed. Experience in regulated environments and the ability to analyze information, communicate clearly, and work effectively with engineers and operations teams is important. This role supports activities within a quality system aligned with applicable medical devices and combination product quality requirements, including FDA QMSR, ISO 13485:2016, ISO 14971:2019, and applicable constituent-part quality requirements under 21 CFR Part 4.

Requirements

Bachelor’s degree in Engineering, Life Sciences, Quality, or a related technical discipline.
Minimum 2–5 years of quality engineering or quality systems experience in a regulated medical device, combination product, biotechnology, or similarly regulated environment.
Working knowledge of quality system requirements applicable to medical devices and/or combination products, including FDA QMSR / 21 CFR Part 820, ISO 13485:2016, ISO 14971:2019 and applicable elements of 21 CFR Part 4.
Experience authoring or revising SOPs, work instructions, forms, templates, validation-related documents, or other controlled quality system documentation.
Experience with change control, document control, nonconformance, CAPA, or other core quality system processes.
Experience working cross-functionally with engineering teams and reviewing technical documentation such as drawings, specifications, design documents, test methods, validation documents, and risk management records.
Ability to manage multiple assignments and deliver high-quality work within timelines in a dynamic environment.
Proficiency in Microsoft Office applications, especially Excel, Word, PowerPoint, and Outlook.
A current US work authorization is required.

Nice To Haves

Preferred experience with electromechanical devices, software-controlled devices, manufacturing process changes, design changes, or validation change impacts.
Preferred background supporting quality metrics, KPI dashboards, trend analysis, or management review reporting.
Preferred experience with eQMS platforms such as MasterControl or similar systems.
Preferred familiarity with risk management tools and structured quality methods such as FMEA, risk assessments, root cause analysis, SPC, DOE, and data trending.
Preferred experience using statistical analysis software such as Minitab, JMP, or comparable tools
Preferred experience supporting combination products, including constituent-part quality system considerations.
Preferred ability to work independently with limited supervision while exercising sound judgment in identifying and escalating compliance or quality risks.

Responsibilities

Support day-to-day activities related to quality engineering and quality systems operations.
Assist with processing and coordinating change control records, including preparing documentation, routing for review/approval, tracking progress, and following up on implementation and closure.
Support preparation, review, and revision of quality system documents (SOPs, work instructions, forms, and quality records) to ensure accuracy, clarity, and compliance.
Review completed records for completeness, accuracy, data integrity, and adherence to applicable procedures and regulatory expectations.
Support collection, compilation, and trending of quality metrics and other data for management reporting, process monitoring, and quality improvement activities.
Assist with preparation of data and materials for Quality Management Review (QMR) and other quality meetings.
Track action items arising from management reviews, CAPAs, design reviews, change controls, deviations, and other quality system activities.
Help identify documentation gaps, incomplete or overdue records, and other quality system issues requiring escalation or corrective action.
Work closely with engineers and other cross-functional team members to obtain technical information required to complete quality records, investigations, and documentation accurately.
Support investigations, CAPAs, and process improvement activities as assigned.
Maintain organized files and records within paper-based and/or electronic quality systems.
Perform other duties as required to support Quality Assurance and quality systems operations in fast-paced environment.