Senior Quality Engineer (Medical Device)

The Senior Quality Engineer will be responsible for overseeing quality management systems and ensuring compliance with industry regulations for medical devices. The role involves supporting design and development, leading investigations of nonconformities, and driving continuous improvement initiatives. The ideal candidate will have strong knowledge of FDA regulations, ISO standards, and experience working within the medical device industry.Key Responsibilities:Lead quality assurance activities in the development and manufacturing of medical devices.Review and approve product specifications, drawings, and engineering documents.Conduct risk management, failure mode analysis, and design validation.Support CAPA (Corrective and Preventive Actions) investigations and ensure resolution of quality issues.Conduct audits and ensure compliance with FDA regulations, ISO 13485, and other relevant standards.Develop and implement quality control processes and tools.Provide guidance and mentorship to junior quality engineers.Collaborate with cross-functional teams to drive quality improvements.Review and approve validation protocols and reports.Qualifications:Bachelor's degree in Engineering, Life Sciences, or related field.5+ years of experience in Quality Engineering within the medical device industry.In-depth knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and other industry standards.Experience with root cause analysis, risk management, and CAPA processes.Strong communication and problem-solving skills.

Created: 2025-01-28