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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

we are responsible to foster quality and excellence in our company's products and processes across the entire company. MEQ focuses on ensuring high customers' satisfaction through continuous improvement and implementation of automotive standards and best-practices such as ASPICE, IATF16949, ISO 9001, VDA/AIAG Core Tools and ISO26262, both internal and across the entire supply chain, In order to support MEQ objectives, The QMS & Production Quality team is looking for a Production Quality & Reliability Engineer
What will your job look like:
Define and implement Quality & Reliability (QnR) framework and workplan for our company's components from first Silicon and onwards (from scratch)
Define and lead/participate in: QnR validation activities, Fault Isolation, Failure analysis according to 8D method, Yield enhancement, SORT kill criteria definition based on reliability risks, Statistical bin limits.
Work closely with colleagues from other departments (PMs, development engineers, production engineers, management) and other organizations (suppliers and customers).
Work with contract manufacturers to analyze the production process, process capability and capacity and measurement systems capability.
Assess and control the activities through performing VDA6.3 audits.
Create, manage and update PPAP folders for components.
Identify opportunities for improvement and execute them.
Create relevant work items templates and coach the teams how to use them.
Assess KPIs of processes and activities and suggest corrective actions and improvement.
Represent components QnR related issues with customers, suppliers and 3rd party organizations.