Quality Engineer II – Quality Systems & Compliance (Contract)

INOVIO PHARMACEUTICALS INC; San Diego (CA); On-site; USD 63,000 - 73,000; Full time

Job summary

INOVIO Pharmaceuticals, Inc. seeks a Temporary/Contractor Quality Engineer II to provide hands-on quality engineering and systems support for product development and pilot manufacturing.

You will create and revise quality records, review data for accuracy, and track action items across cross-functional teams. The role emphasizes adherence to FDA QMSR, ISO 13485:2016, and ISO 14971:2019 requirements, with responsibilities spanning documentation, change control, CAPA, and quality metrics to ensure

Qualifications

• Bachelor's degree or higher in a relevant technical field.
• Experience with regulated environments and medical devices or combination products.
• Knowledge of quality system requirements and regulatory expectations.
• Experience authoring or revising SOPs and quality records.
• Experience with CAPA, change control, nonconformance, and document control.

Responsibilities

• Support day-to-day quality engineering and quality systems operations.
• Prepare, review, and revise quality system documents for accuracy and compliance.
• Review records for completeness and data integrity.
• Collect and trend quality metrics for management reporting.
• Assist with calibration and preventive maintenance activities for equipment.
• Support equipment qualification and validation activities (IQ/OQ/PQ).
• Identify documentation gaps and escalate quality issues as needed.
• Collaborate with cross-functional teams to obtain necessary technical information.
• Assist investigations, CAPAs, and process improvement tasks.

Skills

Quality engineering

Quality systems

SOPs

CAPA

Regulatory compliance

FDA QMSR / 21 CFR Part 820

ISO 13485:2016

ISO 14971:2019

Document control

Change control

Cross-functional collaboration

Electrical/electromechanical devices

Quality documentation

Data analysis

Education

Bachelor’s degree in Engineering, Life Sciences, Quality, or related

Tools

MasterControl

BMRAM

Minitab

JMP

eQMS platforms

Job description

INOVIO Pharmaceuticals, Inc. seeks a Temporary/Contractor Quality Engineer II to provide hands-on quality engineering and systems support for product development and pilot manufacturing.

You will create and revise quality records, review data for accuracy, and track action items across cross-functional teams. The role emphasizes adherence to FDA QMSR, ISO 13485:2016, and ISO 14971:2019 requirements, with responsibilities spanning documentation, change control, CAPA, and quality metrics to ensure