לוח משרות דרושים מנהל איכות | מנהל QA

The Quality Engineering & Manufacturing Manager will support continuance improvement of product, process and QMS and provide guidance and support to all duties associated with the auditing and documentation of compliance related items against GMP and ISO standards and its subcontractors. The Quality Engineering & Manufacturing Manager will also lead a team executing the QMS related transactions in relevant GMP systems (MasterControl, SAP, Share Point) and other relevant quality functions as applicable including external and internal audit support.

Essential Duties and Responsibilities:



Exhibit a strong quality first mentality and ensure that product, process and QMS are held to the highest standard.
Provide guidance on Ops, technical and engineering processes/documentation to ensure compliance to procedures, relevant regulations and standards.
Lead Sr. Quality Eng., team leaders, Quality Engineers and Quality personnel in the day-to-day activities- supervise performance and tasks handling, set priorities, training, and objectives according to the organizational goals.
Lead Sr. Quality Engineers and QEs who review and approve technical/ Engineering documentation (DMR, IQ, OQ, PQ, product specifications, process validation and qualification activities, FMEA risk documents, test methods, protocols, reports, OOSs, design transfer, etc.) in relation to medical devices.
Lead the Quality involvement in design and maintenance of product and production process and hazard analysis in accordance with policies and procedures.
Provide Quality oversight and guidance to design transfer and process qualification and validation activities to other Sr. QEs.
Provide quality oversight, approval and guidance for qualification documentation and reports
Provide direction and guidance with problem solving techniques for technical and process reviews in cases of escalations.
Lead the sites device sterilization methods establishment, validation, maintenance and routine controls as the site sterilization SME by verifying that the sterilization methods validation is done according to the applicable standards and regulations. Verify the sterilization methods and risk-based approach are routinely maintained. Address sterilization issues and provide solutions to sterilization challenges. Be a part of the Global Sterilization Council and provide support to other CM and Medical device sites with Ster

we are currently hiring a
Quality Assurance and Qualified Person Lead (m/f/x)
(fulltime/ permanent)
You will perform all activities as Qualified Person and Quality Manager for the Israeli affiliate of CSL Behring, which is in an establishment phase.
You will implement and maintain the QMS of CSL Behring Israel.
Main Responsibilities and Accountabilities:
Release/ rejection / partial rejection of lots to the Israeli market according to MOH regulations, GMP and GDP requirements
Supervise the rework/repackaging of products
Handle returns and recalls
Prepare and lead MOH audits, assistance and participation in quality audits, either internal or external
Create and update SOPs
Conduct GMP and GDP trainings
Condut supplier audits and qualification
Prepare and present periodic Quality Management Reviews

The Quality Manager will be responsible for validating and controlling quality processes in the company's factories worldwide.

Includes planning work processes, controlling and improving processes, managing quality in the company's factories in Israel and internationally

Responsibilities
Devising quality strategies and implementing them, defining and implementing quality processes
controlling and improving work processes in manufacturing departments
Monitoring, analyzing and improving quality indicators, customer complaints, and supplier complaints
Planning and identifying work processes and examining possible failure points
Constructing annual work plans and defining monitoring reports and statistics in the quality field

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.

n this role, the QA Engineer supports products development and provides quality oversight to the R&D activities while working within a multi-functional team environment for medical devices.

The QA Engineer will play an active role to ensure the design and development process meets quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements as well as being involved in QA activities.



Essential Duties and Responsibilities:

QA focal point for R&D projects in design and development processes.
Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards
Responsible for final approval of R&D documentation- reviewing and approving technical and DHF documentation.
Responsible for approval of product development DHF documentation (DDP, PRD, TMX, design verification & validation activities, dFMEA risk documents, test methods, protocols, reports, product design transfer)
Responsible for approval of product design changes
Finding solutions for queries within responsibility limits
Assist and provide guidance on any out of specification result, deviation, or excursion that may occur
QA representative in product development design reviews
Work cross-functionally with individuals and project or extended teams to provide guidance and ensure success of projects
Attend program meetings as required as part of extended program teams

As a Quality Assurance Leader, you will be responsible for conducting our day-to-day product quality activities. Your role is to ensure that final products adhere to the established quality standards.
Your responsibilities encompass conducting routine and quality inspections, identifying, and resolving workflow and production issues, training, investigating customer complaints, performing supplier evaluations and audits, and review of product specifications and quality control plans.​
Essential Duties and Responsibilities:
Day-to-day quality engineering activities such as product quality documentation, incoming inspection, customer complaints, , product deviation, non-conformities, Document control and fields corrective action
Conducting incoming inspection and evaluating the compliance of products or with requirements, specifications, or standards.
Conducting audits at manufacturers and subcontractors, performing source inspections according to specified drawing/work instructions and quality requirements.
Managing quality processes in the manufacturing, including monitoring, and controlling processes, preparing quality reports and analyses, and maintaining relevant documentation.
Conducting quality inspections on suppliers and incoming raw materials to the factory and ensuring their compliance with required quality standards.
Responsible for leading and implementing IPQC, IQC, OQC approval to supplier.
Establishing metrics and criteria for monitoring suppliers and subcontractors.
Collaborate with Operations, R&D QA, Engineering and Manufacturing functions to ensure quality standards are in place.
Validation of manufacturing process to meet targets, production output and quality standards.

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

About LiveU LiveU is driving the live video revolution, providing live video streaming for TV, mobile, online and social media. Let your audience become part of your story with high-quality and flawless live video, transmitted from anywhere in the world, using our patented bonding and video transport technology. LiveU creates a consistent bandwidth and a reliable connection so you can acquire, manage and distribute high-quality remote live broadcasts. Job Overview: The Organizational Processes Quality Control Manager, plays a pivotal role in ensuring the efficiency, effectiveness, and compliance of our organizational processes, collaborating with cross-functional teams to establish, monitor, and continually improve quality management systems to drive operational excellence. The successful candidate will have a comprehensive understanding of process improvement methodologies, quality standards, proven track record in driving quality initiatives within a global context. As LiveU is a mission critical organization, the primary responsibility is to ensure the overall quality and consistency of products, services, and processes within the organization, developing, implementing, and maintaining a global Quality Management System, driving continuous process improvement, ensuring compliance with industry standards, and fostering cross-functional collaboration within a leading hardware and software company. In this role, the Organizational Processes Quality Control Manager : o Establish an organizational Quality Processes assurance function that will be responsible for developing, implementing, and maintaining a global Quality Management System. o Define key performance indicators (KPIs) to measure and reflect whole company quality and the effectiveness of related organizational processes. o Lead investigations into quality issues, conduct root cause analyses, and implement corrective and preventive actions driving continuous process improvement. o Leads Processes improvements to improve customer quality and customer experience. o Generate regular reports and present findings to senior management, highlighting areas for improvement and success.
Location : Kfar Sava, Israel
Responsibilities: o Develop, implement, and maintain a robust Quality Management System (QMS) across the organization. o Ensure alignment with industry standards and regulatory requirements relevant to hardware and software development. o Identify areas for process improvement and lead initiatives to enhance efficiency, reduce errors, and optimize workflows. o Implement best practices to drive continuous improvement. o Identify and manage “Mission Critical” quality issues. o Investigate and analyze the root causes of “Missions Critical” issues and develop corrective and preventive action plans. o Facilitate and lead problem-solving sessions to address systemic issues affecting quality. o Document and communicate findings and corrective actions. o Lead investigations into quality issues, conduct root cause analyses, and implement corrective and preventive actions o Define key performance indicators (KPIs) to measure the effectiveness of organizational processes. o Generate regular reports and present findings to senior management, highlighting areas for improvement and success. o Develop and maintain process documentation, ensuring accessibility and comprehensibility for all stakeholders. o Conduct training sessions to educate employees on quality processes and standards. o Collaborate with departments across the organization to ensure consistency and alignment of processes. o Act as a liaison between different teams to facilitate communication and understanding of quality objectives.

Implementation of a culture of quality Compliance with regulatory requirements and international standards, including ISO 13485, 21 CFR 820, EU-MDR 2017/745 - Preparation of annual quality plans in collaboration and oversight of their implementation (these plans may include initiatives for improving quality infrastructure, responding to new regulatory requirements/standards, etc.) - Management of the quality department: QC personnel and quality engineers - Professional guidance of all quality functions within the company, such as training, configuration management, supplier controls, incoming inspection, calibrations, customer complaints, CAPA, documentation controls etc. - Conducting quality training within the company - Leading quality audits (customer audits, regulatory bodies, and internal audits) - Leading management reviews - Defining quality goals and metrics in collaboration with management and defining improvement activities as needed.