remote
QA Engineer - FujiFilm
QA Engineer
QA Engineer focused on enhancing quality systems, managing deviations, and ensuring ISO 9001 compliance using risk assessment and validation techniques.
About the role
Key Responsibilities
- Lead continuous improvement of the Quality System, identifying and implementing efficiencies across all QA functions.
- Drive resolution of deviations and product nonconformance, coordinating cross‑functional teams to root cause and remediate issues.
- Conduct risk assessments and maintain risk registers to support product safety and regulatory compliance.
- Manage quality‑related customer support, ensuring timely and accurate responses to inquiries and complaints.
- Ensure all QA and Validation activities meet ISO 9001 requirements and applicable industry standards.
Requirements
- Proven experience in Quality Assurance within regulated environments (e.g., medical devices, pharmaceuticals).
- Strong knowledge of ISO 9001 and related quality standards.
- Excellent analytical, problem‑solving, and communication skills.
- Ability to work independently and collaborate with cross‑functional teams.
Skills
seleniumtest automationcypress