Senior Quality Operations Manager

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.***