Quality Assurance Manager

Medasense is transforming the way PAIN is being assessed and treated worldwide. Through our breakthrough NOL® AI technology and sensing platform, we quantify pain response to optimize care and avoid overmedication.

Medasense’s flagship product, PMD-200™, is used in critical care settings, where patients are unable to communicate, to visualize pain response and personalize treatment. Clinical studies have demonstrated its impact on patient safety and outcomes.

PMD-200™ is distributed in Europe by Medtronic, and is also commercially available in USA, Canada, Latin America, Israel, and additional territories.

Job Description

We are seeking a dynamic and results-driven Quality Assurance Manager to join the Medasense team as we bring meaningful innovation to global markets. The QA Manager will be responsible to develop and implement the company’s quality system throughout the product lifecycle ensuring compliance with all applicable regulatory requirements. Driving excellence in quality at the product and at the system level.

The position reports to the VP of Clinical, RA & QA

Duties and Responsibilities

• Oversee and coordinate the daily operations of the QA department, ensuring all activities align with QMS requirements, business goals and customer requirements
• Developing and maintaining quality documentation, including SOPs, test plans, reports, and defect tracking records
• Conducting root cause analysis of quality issues and implementing corrective actions to prevent recurrence
• Leading the planning and execution of audits, inspections, and tests to evaluate product quality
• Overseeing production activities, product quality and QC activities including qualification and oversight of contract manufacturers, production processes and approval of final release of product for shipment
• Monitoring and analysing key quality metrics to track product performance and identify areas for improvement
• Driving quality improvement and focus on quality
• Working closely with product development, engineering, and operations teams to ensure that quality standards are integrated into the product lifecycle
• Responsible for employee QMS training
• Leading complaint handling activities
• Leading Risk Management processes and ensuring quality risks are mitigated throughout the product life cycle
• Approval of qualification and validation activities
• Approval of qualification of company employees

Requirements

• Bachelor's degree in a relevant field or equivalent experience in medical device quality assurance
• Proven track record as a QA Manager, QA Lead, or similar role, with 3+ years in quality assurance (QA).
• In-depth knowledge of quality assurance methodologies, tools, and frameworks. Experience in using statistical analysis and quality control tools
• Experience with software development lifecycle (SDLC), software testing, defect tracking, and quality management systems
• Strong analytical and problem-solving abilities with attention to detail.
• Excellent communication skills, both written and verbal, with the ability to present complex information to various stakeholders
• Strong organisational and project management skills with the ability to manage multiple priorities simultaneously
• Relevant certification in Quality Management (e.g internal auditor) an advantage
• Fluent in Hebrew and English with excellent verbal and written communication abilities in both languages

Join our passionate team and contribute to transforming patient care with our state-of-the-art pain monitoring devices.