דרושים » מדעי החיים, טבע וחקלאות » Validation engineer

a fast-growing medical technology company transforming the fields of hematology and cell morphology analysis. As a team, we work to enable faster, earlier detection and diagnosis of blood-related diseases, so patients can start treatment sooner and have better outcomes. We are collaborative and global and every individual at is part of a life-saving mission.

About the job
We are looking for a compliance analyst to join our compliance and RA team, which plays a central role in both pre-market and post-market activities. The team is responsible for regulatory activities, quality management system, and ensuring compliance with applicable standards, including those related to privacy.

The analyst will play an important role in the companys regulatory, quality and compliance activities, such as ensuring compliance with relevant quality standards (including ISO 13485:2016, 21 CFR 820, MDSAP and IVDR); supporting internal audits, corrective efforts and different quality projects; and defining quality procedures, protocols and tools.

What youll be doing
Provide ongoing support for the companys quality management activities, including SDLC, PMS, product investigation, operations, training management, supplier management, and document control
Maintain the companys quality management system (QMS)
Evaluate and address quality assessment related to customer complaints
Prepare and maintain technical documentation in compliance with standards such as ISO 13485, 21 CFR 820, and IVDR
Collaborate with cross-functional teams, including R&D, product development, and technical support on quality-related activities
Perform privacy-related tasks, such as evaluating suppliers for privacy compliance and reviewing data processing agreements (DPAs)
Analyze post-market surveillance data to support company initiatives
Prepare teams for internal and external audits

Medison offers hope to patients suffering from rare and severe diseases, by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets. As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead, and work relentlessly to bring therapy to patients in need, no matter where they live. Our values are at the core of every action we take, and we are committed to going above and beyond for the benefit of the patients we serve. We are a dynamic, fast-paced company, operating in over 25 countries on 5 continents. We are looking for out-of-the-box thinkers, people who are passionate, caring, agile and adaptive, to join us on our mission. If you are looking to make a difference in people's lives, we invite you to join us! The position includes all aspects of quality assurance for all companies in the group. Job includes: Drafting new SOPs and updating existing SOPS and reports according to GMP and GDP regulations. Build and follow up work processes, set yearly training and conduct continuous training sessions for employees and suppliers. Document training. Conduct validation and monitor prevention and improvement activities (CAPA). Assist in preparing for inspections, executing internal auditing and partner audits as needed. Qualify suppliers, manage investigations and deviations. Risk management and support regulatory and operations divisions. Prepare specified yearly quality reports and be of assistance to manager in any way required. Quality activities are not inspections, rather supervision. The purpose is to coordinate the company's management and regulatory efforts in a specific field.

Responsibilities:

* Ensure that the quality assurance system is implemented in a way that the approved activities can be managed.
* Ensure precision and quality where listed and approve inspected documents.
* Supervising that employee training is implemented and maintained.
* Handle changes and deviations according to managers' requirements. Implement preventative and correction measures when necessary.
* Ensure implementation of periodic management survey.
* Ensure implementation of risk management.
* Ensure that suppliers and partners are approved and qualified.
* Approve every activity performed by sub-contractor that may indicate the quality of the
* products.
* Implement and ensure that internal inspections are carried out regularly and according to a set plan and ensure that corrective actions are set up after inspections.
* Keep account of all assignments carried out for person/company.
* File all relevant documentation.
* Carry out any task requested by superior.
* The role includes leading, coordinating and performing, validation and calibration activities in the warehouse areas and distribution-- vehicles. Occasionally, early work hours are require

a rapidly growing medical technology company revolutionizing hematology and cell morphology analysis. Our mission is to facilitate quicker, earlier detection and diagnosis of blood-related diseases, ultimately leading to improved patient outcomes. At every team member plays a crucial role in our life-saving mission.

About our technology
developed a groundbreaking digital imaging platform utilizing innovative computational photography and clinical-grade AI. This platform automatically analyzes blood samples at the highest resolution available and delivers results within minutes. Our Full-Field Peripheral Blood Smear Application has received FDA clearance, and our technology is currently in commercial use across hospitals and labs in the US, Europe, and Israel.

What youll be doing
Collaborating with cross-functional R&D teams to enhance development and testing processes
Designing and developing test infrastructure, both back-end and front-end
Creating and executing comprehensive test plans, test suites, and test scripts to validate functionality, performance, integration, and security
Reporting metrics, test results, and defects to stakeholders
Developing, executing, and maintaining automated testing frameworks
Preparing and maintaining relevant documentation and technical guidelines