Job Description
Position Overview
The Quality Engineer plays a key role in ensuring that our products, processes, and systems meet regulatory, customer, and internal quality standards. This role involves supporting quality management systems, driving continuous improvement initiatives, and working cross-functionally with engineering, operations, and regulatory teams.
Essential Duties and Responsibilities:
Design Controls
The Quality Engineer plays a key role in ensuring that our products, processes, and systems meet regulatory, customer, and internal quality standards. This role involves supporting quality management systems, driving continuous improvement initiatives, and working cross-functionally with engineering, operations, and regulatory teams.
Essential Duties and Responsibilities:
Design Controls
- Ensure compliance with design control requirements (21 CFR 820.30, ISO 13485) throughout product development
- Review and approve design inputs, outputs, verifications, validation, and design transfer deliverables
- Partner with R&D and product development teams to ensure requirements traceability from concept to commercialization
- Lead risk management activities per ISO 14971, including hazard analysis, FMEAs,...
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