Quality Engineer II

About the role

The Quality Engineer II supports and maintains quality assurance activities within an In Vitro Diagnostics (IVD) manufacturing and development environment. This role ensures compliance with applicable regulatory requirements, including U.S. Food and Drug Administration regulations (21 CFR Part 820), ISO 13485, and other global standards governing medical devices and diagnostic products.

Responsibilities

• Execute quality engineering tasks for manufacturing support
• Write and review protocols (IQ, OQ, PQ, TMV)
• Support design transfer and risk management activities
• Lead problem-solving using root cause methodologies
• Participate in internal audits
• Cross train and perform other interdepartmental responsibilities as required.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field
• Advanced degree in a technical field with required relevant work experience
• 3-6 years of quality assurance or manufacturing experience in relevant industry required

Skills

• Working knowledge of quality systems in IVD
• Experience in process validation, test method validation
• Familiarity with ISO 13485 and FDA QSR
• Strong analytical and documentation skills