לוח משרות דרושים מנהל איכות | מנהל QA בשרון

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

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

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.

A leading technology defense company is looking for a seasoned Director of Quality Assurance
The Director of QA will play a pivotal role in leading and managing the quality system within the company.
Reporting directly to the VP of APEX and Compliance, this position will be responsible for defining, developing, and maintaining processes, methods, procedures, and tools that support the overall quality system.
Key Responsibilities:
Manage the quality department at Netanya and Beit Shean and lead all quality activities at the different product life cycle stages
Oversee and lead the company's quality system, ensuring compliance with relevant standards and regulations.
Work closely with regulatory bodies, preparing for external audits, and ensuring ongoing compliance with regulations.
Define, develop, and maintain processes, methods, procedures, and tools that support the quality system.
Implement and monitor quality planning and control throughout all stages of the product life cycle. Collect, analyse, and report quality data at all stages of the product life cycle.
Provide training in relevant areas to ensure a high level of competency and awareness of quality standards.
Manage customer relations on relevant quality issues, including document preparation, handling customer complaints, and conducting customer satisfaction surveys.
Oversee subcontractor and procurement control, including qualification, inspections, failure investigations, maintenance activities, and continuous improvement initiatives.
Lead and concentrate activities necessary for the preparation and conduct of effective management surveys to meet quality objectives, while continuously improving and increasing efficiency.

DRS RADA Technologies, a leading technology defense company is looking for a seasoned Director of Quality Assurance The Director of QA will play a pivotal role in leading and managing the quality system within the company. Reporting directly to the VP of APEX and Compliance, this position will be responsible for defining, developing, and maintaining processes, methods, procedures, and tools that support the overall quality system. Key Responsibilities:
* Manage the quality department at Netanya and Beit Shean and lead all quality activities at the different product life cycle stages
* Oversee and lead the company's quality system, ensuring compliance with relevant standards and regulations.
* Work closely with regulatory bodies, preparing for external audits, and ensuring ongoing compliance with regulations.
* Define, develop, and maintain processes, methods, procedures, and tools that support the quality system.
* Implement and monitor quality planning and control throughout all stages of the product life cycle. Collect, analyse, and report quality data at all stages of the product life cycle.
* Provide training in relevant areas to ensure a high level of competency and awareness of quality standards.
* Manage customer relations on relevant quality issues, including document preparation, handling customer complaints, and conducting customer satisfaction surveys.
* Oversee subcontractor and procurement control, including qualification, inspections, failure investigations, maintenance activities, and continuous improvement initiatives.
* Lead and concentrate activities necessary for the preparation and conduct of effective management surveys to meet quality objectives, while continuously improving and increasing efficiency.

In this role, you will be supporting post-production related Quality activities such as finished batch release, including sterilization and LAL processes release, graphics and work order approval and support additional quality department activities.



Essential Duties and Responsibilities:



Responsible for the commercial (human use) and R&D (Not for Human Use) batch release activities including review and approval of the finished Device History Record documentation and Certificate of Compliance issuing.
Responsible to review and approve GAMMA/ EtO sterilization documentation, LAL (Endotoxin) test documentation.
Responsible to review and approve of graphics artwork for Tyvek, Labels and relevant cartons.
Responsible to approve production/R&D work orders in ERP
Responsible to review and approve of samples/R&D (not for human use) batch release including review and approval of the finished Device History File documentation and Certificate of Compliance issuing.
Initiate Nonconforming Product in SAP related to finished batch release and sterilization processes
Support preparations for periodical management reviews
Participation in external audits (notified body and customers)
Write and update quality system procedures
Support QA dept activities- customer complaints, QA monthly report, KPIs, etc.

n this role, the Engineering & Manufacturing Quality Manager leads Sr. Quality Engineers, Quality Engineers and personnel who provide quality oversight the Ops Quality platform, such as Engineering, process validations, production lines development and qualifications, material acceptance, Quality presence at production and manufacturing failure investigations while working within a multi-functional team environment for medical devices. The Quality Engineering & Manufacturing Manager leads personnel who review and approve projects, tasks and nonconformities, from product realization, design transfer, production process establishment and changes, production controls and manufacturing supervision and plays an active role to ensure that production processes meet all applicable quality standards, consistent with internal procedures and acceptance criteria, while meeting applicable regulatory requirements. The Quality Engineering & Manufacturing Manager will be a strong advocate for product and process quality at all stages. Additionally, this role leads Sr. Engineers responsible for the medical devices sterilization methods establishment, validation, control, and maintenance activities. Furthermore, the Quality Engineering & Manufacturing Manager leads personnel who are responsible for the production documentation (DHR) and finished product release to market by monitoring the manufacturing and release processes, including a verification that the sterilization and Endotoxin levels meet the applicable requirements.

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 for West and its subcontractors. The Quality Engineering & Manufacturing Manager will also lead a team executing the QMS related transactions in relevant GMP systems (Master Control, SAP, Share Point) and other relevant quality functions as applicable including external and internal audit support.

In 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

What to join a team of excellence professionals ? -LiveU is looking for an Operations Quality Assurance Manager! LiveU is the market leader for live news and dynamic sports coverage, with flawless 5G, 4K HEVC live streaming, and remote production. Together with its cloud-based management and next-gen IP distribution platforms, LiveU offers the most cost-effective end-to-end contribution, production, and distribution solution.
In this role you will play a critical role in ensuring the overall quality and consistency of our hardware products and global operations processes. You will collaborate closely with cross-functional teams to establish and maintain our quality standards, conduct audits, and drive continuous improvement initiatives in a dynamic and innovative high-tech environment. This role requires a hands-on approach to create a culture of excellence and drive operational efficiencies. If you're passionate about quality assurance and driving operational excellence, we want to hear from you!

Basic requirements:


* Minimum 5 years of experience in a similar quality management role within a high-tech hardware global company.
* Demonstrated experience in team management, with the ability to motivate and develop team members to achieve departmental goals.
* Strong background in quality studies and practical experience in quality management systems.
* Excellent analytical, problem-solving, and communication skills with the ability to effectively communicate complex technical concepts to stakeholders at all levels .
* Bachelor’s degree in engineering or science.
* Hands-on experience managing FACA processes and tools to drive visibility and accountability for quality issues .
* Proven ability to work collaboratively in a cross-functional environment, building strong relationships with stakeholders across departments.
* Fluent in English and Hebrew, both spoken and written.