לוח משרות דרושים מנהל איכות | מנהל QA משרה מלאה

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.

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, 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.

Position Title: Quality Assurance Leader.
Reporting To: Quality Engineering team leader.
Location: Afikim, Israel.
 
Job Description
As a Quality Assurance Leader, you will be responsible for conducting our day-to-day product quality activities. Your role is to ensure that our 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 include the following (Other duties may be assigned):
* 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.

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.

The Development Quality Assurance Manager is responsible for assuring quality over-sight for activities undertaken in all entities in a country to assure compliance with relevant Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) regulations and guidelines to assure the execution of high quality research and activities within a country(ies).

You will also be responsible for assuring the quality and compliance of Development, Global and local Medical Affairs (MA) & Commercial patient-facing projects, products and programs. Operates in direct collaboration with local Development colleagues (Study and Site Operations, Patient Safety and Regulatory Affairs), Medical Affairs and Country QA to ensure compliance to entities requirements and relevant HA regulations and guidance.

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

we are looking for a Visual QA Specialist
RESPONSIBILITIES
Review the product and new features from the end-user perspective
Examine simulated driving videos in different edge cases
Cross-version research of product weaknesses visible to the end-user
Measure the impact of new features on product gaps
Create and execute ATP/STD for version release