Job ScopeThe Quality Engineer II is responsible for supporting and maintaining 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.
The Quality Engineer II applies intermediate-level technical knowledge to support product lifecycle processes, including design controls, risk management, process validation, and production quality. This role partners cross-functionally with Manufacturing, R&D, Regulatory Affairs, and Supply Chain to ensure product quality and continuous improvement.
Duties & Responsibilites- 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.
- Other duties as assigned
Education, Experience & 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
- Certification in a quality discipline, such as ASQ certified Quality Engineer (CQE), Quality Auditor (CQA), Six Sigma black belt, etc.preferred
Training & 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
Travel- 10% Domestic travel may be required
- 5% International travel
