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Responsibilities

• Establish and enhance quality functions related to both Sunrise’s QMS and to delivery of engineering services to Sunrise’s clients
• Oversee the development and implementation of the company quality management system (QMS), ensuring adherence to regulatory standards, and driving  continuous improvement
• Act as  Sunrise’s Quality representative on client engagements to ensure compliance with applicable QMS and regulatory standards
• Develop and maintain a robust QMS aligned with ISO 13485 and regulatory requirements 
• Define the organization's quality strategy and establish clear objectives 
• Create and maintain QA training from onboarding to offboarding 
• Work closely with engineering and other teams to integrate quality considerations into processes and client projects
• Prepare for and manage external audits and inspections
• Drive a culture of continuous improvement in quality processes
• Build and mentor a high-performing quality team consisting of both direct and indirect reports
• Implement and oversee CAPA (Corrective and Preventative Actions) system
• Refine finished product release process
• Support HHE (Health and Hazard Evaluations) for employee safety in the workplace 
• Present Management Review on Metrics (NCMRs, CAPAs, Supplier Quality, Audits,  etc.)
• Support Customer Communication Processes establishment
• Support Supplier Audits and Supplier Monitoring

• Bachelor's degree in science or engineering. (Master's degree is a plus)
• Minimum 8 - 10 years of quality management experience within the medical device industry and with the product development process
• In-depth knowledge of FDA regulations, ISO 13485, and other quality standards related to the design of medical devices and equipment
• Proven track record of implementing and managing quality management systems
• Strong leadership, communication, and interpersonal skills
• Excellent problem-solving and decision-making abilities
• Ability to lead within ambiguity and pivot quickly in a rapidly changing environment

https://recruiting.paylocity.com/Recruiting/Jobs/Details/3442184