We are looking for an experienced Director of Quality Assurance to join our team.

Do you want to be part of an international team of dreamers and doers that impact the world every day? Do you want to contribute to advancing medicine by leveraging cutting-edge technologies and forward our mission of quality of care for people regardless of who and where they are? Then, this opportunity might be for you! This role is open for future USA or EU colleagues. 

As a Quality Assurance Director at Trice, you will be responsible for developing and implementing a SaMD medical device quality management system and risk management strategies for a global portfolio.  To succeed in this role, you will execute compliance and administrative activities while providing expert guidance to support the Quality Management System (QMS).

Responsibilities:

• Responsible for performing tasks to support the maintenance of the quality management system and uphold the quality policy

  
  

• Handle supplier/vendor qualification activities and monitoring activities
  
  

• Support regulatory to develop and implement MDR strategy for individual markets
  
  

• Ensures procedures and practices are continually monitored and compliant to global MDR requirements
  
  

• Leads cross-functional post-market surveillance, compliance, and continual improvement reviews related to product feedback, development, and roadmap prioritizations
  
  

• Lead CAPA process and ensure corrective actions are established and root cause mitigated or remediated
  
  

• Leads continuous improvement activities related to product feedback, and roadmap prioritizations
  
  

• Communicates with regulatory bodies and competent authorities to ensure adequate information is provided, issues are addressed, registration and licenses are up-to-date
  
  

• Ensures regulatory submissions/registrations/approvals are completed in accordance with requirements

  
  

• Ensures regulatory review and maintenance of the quality system by reviewing and approving changes, leading quality planning and management reviews
  
  

• Manages MDR audit planning, preparation, and execution and coordinate corrective actions resulting from audit findings
  
  

• Works with all departments to address audit nonconformances and any other internally/externally identified issues
  
  

• Oversees and manages compliance training

• Oversees and leads Management Review, leads and tracks monitoring metrics

  
  

Requirements:

• Seven to ten years of experience in a regulated healthcare environment with clinical workflows and software medical devices
  
  

• Experience with ISO 13485 / ISO 14971 / FDA QSR-QMSR / EU MDR / IEC 62304/ IEC 62366
  
  

• Experience managing tasks and projects through to completion 
  
  

• Ability to work under direct or minimal supervision
  
  

• Expert understanding of standards, regulations and best practices within regulated healthcare industry
  
  

• Basic experience in use of eQMS, Google, Atlassian products and similar applications
  
  

•  Experience with integrated compliance requirements in related information security and privacy domains

  
  

Performance Metrics (Annual):

• Responsiveness
  
  

• Attention to detail
  
  

• Leadership, participation, and engagement with projects/tasks
  
  

• High quality deliverables
  
  

• Ability to be a team player
  
  

• Alignment with company mission and culture

  
  

Working at Trice, you will contribute to real, mind-blowing innovation and be part of a team of inspiring, high-energy, outstanding colleagues distributed across the US, Europe, and Asia. Are you up for it?

To apply, simply email your cover letter and resume to jobs@triceimaging.com