Be a key player in quality assurance for medical devices as a proactive Quality Engineer. Utilize your solid foundation in FDA regulations and validation processes to foster compliance and continuous improvement.
This role requires a commitment to quality within a regulated environment, supporting quality systems and leading CAPA initiatives. Engage in cross-functional collaborations to implement process improvements while ensuring adherence to regulatory standards during audits and documentation review.
Key Responsibilities:
• Support quality systems for regulatory compliance
• Lead CAPA investigations and conduct root cause analysis
• Maintain, review, and update quality documentation
• Collaborate with teams for effective process improvements
• Assist in managing audits and resolving findings promptly
Requirements:
• 3+ years of experience in Quality Engineering for medical devices
• Strong knowledge in FDA regulatory frameworks and ISO 13485
• Exper...