לוח משרות דרושים מנהל איכות | מנהל QA במרכז

The QA Lead will manage a group of QA Engineers working in the development Agile teams and will be involved in all the phases of the products life cycle, from the design to the delivery and to the operation and maintenance. QA Lead will work closely with our Product department providing R&D feedback to the product requirements and verifying that the features are developed as per their PRDs. This position requires about 80% of hands-on involvement in tests automation, documentation and other daily QA activities.
 Location:
Petah Tikva, IL

we are looking for a Quality Compliance Manager
Essential Duties and Responsibilities:



Exhibit a strong quality first mentality and ensure that QMS processes are held to the highest standard, Support the sites continuous quality improvement projects.
Lead QA Specialists/Engineers in the day-to-day activities- supervise and monitor over the employees performance and tasks handling, training, and objectives according to the organizational goals.
Work cross-functionally with other team managers and project teams leaders to provide QA guidance and ensure success of projects and support other QA dept activities- second approval of batch release and graphics, CAPA/Corrections, quality agreements.
Lead Quality Management System compliance (EN ISO/ISO 13485 and MDSAP) and Quality System activities related to regulatory requirements (such as MDR 2017/745, MDSAP, etc.).
Lead QA Specialists/Engineers who are responsible for customer complaints handling- investigation, root cause analysis, Risk Based Approach, applicable corrections/corrective actions, Returned Material Authorization (RMA) and Returned Goods Authorization (RGA) handling.
Lead QA Specialists/Engineers who are- responsible for the sites complaints trending, support RA in identifying Adverse Events/Hazardous situations and provide inputs into the applicable product and process risk management (dFMEA/pFMEA).
Lead QA Specialists/Engineers who are- responsible for the sites supplier quality management, audits, Quality agreements, SCARs, point of contact to customer/third party related matters/ inquiries/ questionnaires, Perform supplier/subcontractor and internal audits.
Lead the sites external audit program- verifying the readiness of all applicable personnel and processes, execute CDAs with the auditing party, perform preparations meetings with functional managers/team leaders/personnel. Execute External audits by any third party, customer, applicable regulatory authorities, and Notified Body, while working within a multi-functional team environment for medical devices. Perform routine follow ups on External audits status, issue Corrections/Corrective actions and communicate responses to third party, customer, applicable regulatory authorities, and Notified Body.
Lead the sites quality system procedures maintenance by verifying their compliance to relevant regulatory requirements, and their alignment with applicable west Enterprise procedures.
Leading the site preparations of periodical management reviews.
Lead the risk management policy file maintenance activities.

We are looking for a medical technology startup company
Director Quality Assurance Manager
location: Petah Tikva
Job description: Providing management and control of the Quality Assurance processes Experience in team management Initiate, monitor, and verify the effective implementation of the Quality Management system (QMS) in all areas of company activities. Identify potential risks before they become a problem, focusing on root cause analysis and preventive action. Vast knowledge in ISO13485/21CFR, MDR Managed and led external audits and worked with notified bodies. Manage and perform internal and external quality audits and inspections and compile detailed reports of findings. Manage the quality aspects of the manufacturing and clinical processes including feedback, complaints, and technology malfunctions and
failures. Manage suppliers' evaluation and approval. Ensuring all processes are controlled and monitored. Documenting new and existing processes Training and mentoring company employees and sub-contractors on the quality management system Maintains the quality infrastructure of the company.

We are seeking a highly skilled QA and Design Control Manager with proven experience in the medical devices industry to join our team and contribute to the effective maintenance of our (MDR) ISO13485 certified Quality Management System and move us ahead with implementation of QMS that is compliant with FDA 21 CFR Part 820 regulation.
Key Responsibilities:
Responsible for managing or governing all QMS-related processes per ISO 13485 standard e.g., CAPA, Nonconformance, Changes, Complaints handling, Recalls, Data analysis, Risk management.
Assuring production line compliance and working closely with the QA at the contracted manufacturer.
Ensuring compliance with in-house procedures through ongoing, periodic audits or inspections.
Provide professional QA and Regulatory guidance throughout the entire product lifecycle: from the early feasibility through planning, and development until the post-marketing stages.
Guidance by the Design and Development requirements per ISO13485 and Product Realization.
Maintaining design control activities by ISO13485.
Ensuring validation processes are performed and documented.
Provide support for risk analysis processes and technical file maintenance.
Working closely with the Medical Engineering team and R&D team
Making the quality world accessible to the Engineering and R&D team
Reports directly to the VP of Regulatory Affairs & QA

In this role, the Quality Compliance Engineering Manager leads a team of Quality Specialists who are responsible for the feedback system in the QMS- customer complaints handling, complaints trending, RMA and returned goods, issuing corrections and corrective actions related to complaints and Quality reports. The Quality Compliance Engineering Manager also leads the sites external audit program, preparedness, and execution by any third party, customer, applicable regulatory authorities (including Notified Body), while working within a multi-functional team environment for medical devices. As a part of the preparedness for external audits, the Quality Compliance Engineering Manager ensures that all applicable activities done by all company employees meet applicable quality standards, consistent with internal procedures and acceptance criteria, while meeting applicable regulatory requirements. The Quality Compliance Engineering Manager also leads the supplier quality management system, audits, Quality agreements, SCAR, etc.

The Quality Compliance Engineering Manager will be a strong advocate for quality, supporting the sites abilities to meet all applicable and current versions of the Quality and Regulatory requirements, such as EN ISO/ISO 13485, Medical Device Regulation (MDR) 2017/745 and MDD 93/42/EEC, MDSAP, ISO 14971.

The Quality Compliance Engineering Manager supports continuance improvement of the QMS, site procedures alignment with applicable Regulatory requirements, alignment with the Enterprise Quality System and provides guidance and support to all duties associated with the auditing and documentation of compliance related items against GMP and ISO standards for us and its subcontractors. The Quality Compliance Engineering Manager will lead a team executing the QMS related transactions in relevant GMP systems (MasterControl,SAP, Share Point) and other relevant quality functions, as applicable.

The Quality Assurance (QA) Manager will oversee the activity of the quality assurance in Evinced, developing, implementing, and maintaining a system of quality and reliability testing for the organization's products and/or development processes.

As the QA Manager, you will play a crucial role in ensuring the delivery of high-quality products helping enterprises make their web and mobile offerings accessible to everyone.

Your leadership and expertise will be instrumental in providing outstanding features to our vast user base. You will collaborate closely with developers, product teams, and stakeholders in a fast-paced, agile environment, working towards continuous deployment and enhancing the user and developers experience of our offering.

If you are passionate about delivering top-notch applications, thrive in a challenging and innovative setting and want to bring a real impact to the world - Evinced is the right place for you.

Your Impact & Responsibilities:
Lead and manage a team of QA engineers in charge of all aspects of Evinced quality assurance - manual, test automation & performance, including mentoring, training, and task assignment.
This role is hands-on, with at least 50% direct participation in QA activity.
Collaborate closely with cross-functional teams (developers, product managers and designers) ) to ensure seamless coordination and delivery of high-quality products.
Communicate quality requirements, process and plans to team members, stakeholders, and developers.
Analyze test results, metrics, and data for continuous improvement in the QA process.
Proactively anticipate potential issues and work plans about to go off track, suggest improvements, and implement preventive measures.
Plan, own, and execute QA roadmap to align with R&D, and Product roadmaps.
Proactively and constantly push for continuous improvement within and outside the QA department.

This position will be based in our Tel Aviv office, located 5- minute' walk from Hashalom train station. We also have our own parking lot. We work in a hybrid mode, with flexible working hours.