Quality Systems Engineer II — Med Device/BioTech

Inovio; San Diego (CA); Vor Ort; USD 90.000 - 110.000; Vollzeit

Zusammenfassung

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

You will assist with SOPs, records, and data review while ensuring regulatory compliance. The role requires attention to detail, effective communication with engineering and operations teams, and experience in a regulated environment aligned with FDA QMSR, ISO 13485, and ISO 14971.

Qualifikationen

• Bachelor's degree in a technical field and 2–5 years in regulated quality work.
• Experience with quality systems in medical devices or combination products.
• Experience authoring SOPs and change control documents.
• Familiarity with ISO 13485, FDA QMSR, and 21 CFR Part 4.

Aufgaben

• Support day-to-day quality engineering and quality systems operations.
• Prepare, review, and revise quality records and SOPs for compliance.
• Review records for completeness, accuracy, and data integrity.
• Collect and trend quality metrics for management reporting.
• Assist with calibration, maintenance, and equipment qualification.
• Support CAPAs, investigations, and process improvements.

Kenntnisse

Quality engineering

Documentation

Cross-functional teamwork

MS Office proficiency

Ausbildung

Bachelor's degree in Engineering, Life Sciences, Quality or related discipline

Tools

MasterControl

BMRAM

Minitab/JMP

Jobbeschreibung

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

You will assist with SOPs, records, and data review while ensuring regulatory compliance. The role requires attention to detail, effective communication with engineering and operations teams, and experience in a regulated environment aligned with FDA QMSR, ISO 13485, and ISO 14971.