Quality Engineer II (Temporary/Contractor)

INOVIO PHARMACEUTICALS • San Diego, CA

4d

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, record review, and follow-up on action items. This role will assist with implementation and maintenance of quality processes related to 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 with equipment qualification and computerized systems.
• 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 experience with eQMS platforms such as MasterControl or similar systems.
• Preferred Experience using electronic calibration, maintenance, and asset management systems, preferably Blue Mountain Regulatory Asset Manager (BMRAM).
• 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.
• Six Sigma Green Belt, Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or other relevant quality certification preferred.

Responsibilities

• Support day-to-day activities related to quality engineering and quality systems operations.
• 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.
• Support manufacturing related activities such as calibration and preventive maintenance programs for manufacturing, laboratory, inspection, and quality equipment.
• Support equipment qualification and validation activities, including IQ/OQ/PQ documentation as assigned.
• 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.

Benefits

• attractive benefits package

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level