Senior Quality Operations Manager

Description

At Dario, Every Day is a New Opportunity to Make a Difference.

We are seeking an experienced Senior Quality Operations Manager to join our team and ensure comprehensive quality compliance across all manufacturing operations. This role is critical in maintaining our commitment to national and international quality standards while supporting product realization from design through delivery. 

 The primary responsibilities of this job include:

• Ensure full compliance with national and international quality standards related to medical device operations, including but not limited to Manufacuring, supplier controls, risk management. 
• Monitor and assess quality controls across all manufacturing processes and product lines 
• Identify, assess, and mitigate quality-related risks across the manufacturing lifecycle 
• Manage corrective and preventive action (CAPA) processes in collaboration with relevant teams 
• Establish and maintain supplier quality performance criteria and metrics 
• Monitor supplier performance through data analysis, scorecards, and regular assessments 
• Conduct supplier audits to ensure compliance with quality standards and specifications 
• Lead supplier evaluation, approval, and ongoing monitoring processes 
• Manage Supplier Corrective Action Request (SCAR) processes 
• Work closely with R&D teams to monitor and support design control processes 
• Manage and approve Design History Records (DHR) and associated nonconformance documentation 
• Possess authority to perform comprehensive internal and external audits 
• Lead and maintain Material Review Board (MRB) processes 
• Drive continuous improvement initiatives to enhance quality performance 
• Lead cross-functional quality initiatives and improvement projects 
• Lead internal and external audits 

Requirements

• Bachelor's degree in engineering, Quality Management, or related technical field 
• Minimum 5-7 years of experience in quality management within manufacturing environment 
• Experience with regulated industries (medical devices-In-vitro Dianostics, Healthcare, Digital Health) preferred 
• Proficiency in English 
• ISO 13485 Lead auditor certificate preferred 

***DarioHealth promotes diversity of thought, culture and background, which connects the entire Dario team. We believe that every member on our team enriches our diversity by exposing us to a broad range of ways to understand and engage with the world, identify challenges, and to discover, design and deliver solutions. We are passionate about building and sustaining an inclusive and equitable working and learning environments for all people, and do not discriminate against any employee or job candidate.​***