דרושים » ייצור ותעשייה » Director of Quality

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 Quality Assurance Compliance Specialist 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 Quality Assurance Compliance Specialist 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

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 looking for Quality Manager with a 5 years experience.

This position will be responsible for overseeing the quality within the company, focusing on the development, implementation, and monitoring of quality methodologies and processes.

The role will be hands-on, including internal quality control, supplier audits, development of quality documentation, and management of multidisciplinary processes within the company.

The Quality Manager will work closely with our development & engineers, production, and regulatory teams to ensure compliance with rigorous quality standards.

Key Responsibilities:
Developing Quality Methodology: Develop and implement comprehensive quality methodologies, focusing on multi-disciplinary products (including hardware, electronics, mmechanics and software).
Hands-on Role: Perform independent quality control, design, and manage continuous quality improvement processes.
USO Certification and Quality Control: Ensure compliance with international quality certifications and standards, such as ISO, and specific defense standards (e.g., MIL-STD).
Supplier Audits: Conduct quality audits for suppliers in the hardware and electronics domains, analyze results, and provide recommendations for improvement.
Organizing Proposals and Processes: Define processes for organizing proposals and ensure quality requirements are met during supplier engagement.
Quality Documentation: Create and update technical documents, quality reports, specifications, and standard operating procedures.
Collaboration with Development and Production Teams: Coordinate with development, engineering, production, and regulatory teams to ensure compliance with quality standards.
Failure investigations, PFMEA management, MRB committees, and more.

We are seeking an experienced Quality Assurance Manager to lead our quality initiatives and ensure compliance with global standards. This role is integral to maintaining our high manufacturing standards, driving continuous improvement, and collaborating with cross-functional teams to enhance product quality and performance.

Joining us means becoming part of a cutting-edge, fast-growing company that values innovation, excellence, and teamwork in shaping the future of smart materials.

*** Please send a copy of your CV in English.

Responsibilities:
Drive quality performance and continuous improvement across the organization.
Develop and implement product quality assurance strategies across all development phases.
Define QA compliance objectives and ensure adherence to international standards (ISO 9001, VDA 6.3, IATF 16949).
Establish quality control methods, documentation, and risk management practices (FMEA, APQP, PPAP, SPC, MSA).
Investigate root causes of deviations with R&D and production teams, ensuring corrective actions.
Oversee supplier evaluations, internal audits, and customer compliance audits.
Train and supervise technical staff in quality processes, testing, and reporting.
Serve as the product safety representative and liaise with global quality teams.
Prepare for and manage internal, customer, and certification audits.
Willingness to travel internationally when required.

Gauzy (NASDAQ: GAUZ) is a world-leading material science company, focused on the research, development, manufacturing, and marketing of vision and light control technologies that support safe, sustainable, comfortable, and agile user experiences across various industries. We are seeking an experienced Quality Assurance Manager to lead our quality initiatives and ensure compliance with global standards. This role is integral to maintaining our high manufacturing standards, driving continuous improvement, and collaborating with cross-functional teams to enhance product quality and performance. Joining Gauzy means becoming part of a cutting-edge, fast-growing company that values innovation, excellence, and teamwork in shaping the future of smart materials. *** Please send a copy of your CV in English.

Responsibilities:

* Drive quality performance and continuous improvement across the organization.
* Develop and implement product quality assurance strategies across all development phases.
* Define QA compliance objectives and ensure adherence to international standards (ISO 9001, VDA 6.3, IATF 16949).
* Establish quality control methods, documentation, and risk management practices (FMEA, APQP, PPAP, SPC, MSA).
* Investigate root causes of deviations with R&D and production teams, ensuring corrective actions.
* Oversee supplier evaluations, internal audits, and customer compliance audits.
* Train and supervise technical staff in quality processes, testing, and reporting.
* Serve as the product safety representative and liaise with global quality teams.
* Prepare for and manage internal, customer, and certification audits.
* Willingness to travel internationally when required.

The position includes all aspects of quality assurance for all companies in the group. Job includes: Drafting new SOPs and updating existing SOPS and reports according to GMP and GDP regulations. Build and follow up work processes, set yearly training and conduct continuous training sessions for employees and suppliers. Document training. Conduct validation and monitor prevention and improvement activities (CAPA). Assist in preparing for inspections, executing internal auditing and partner audits as needed. Qualify suppliers, manage investigations and deviations. Risk management and support regulatory and operations divisions. Prepare specified yearly quality reports and be of assistance to manager in any way required.

Quality activities are not inspections, rather supervision. The purpose is to coordinate the company's management and regulatory efforts in a specific field.

Responsibilities:
Ensure that the quality assurance system is implemented in a way that the approved activities can be managed.
Ensure precision and quality where listed and approve inspected documents.
Supervising that employee training is implemented and maintained.
Handle changes and deviations according to managers' requirements. Implement preventative and correction measures when necessary.
Ensure implementation of periodic management survey.
Ensure implementation of risk management.
Ensure that suppliers and partners are approved and qualified.
Approve every activity performed by sub-contractor that may indicate the quality of the products.
Implement and ensure that internal inspections are carried out regularly and according to a set plan and ensure that corrective actions are set up after inspections.
Keep account of all assignments carried out for person/company.
File all relevant documentation.
Carry out any task requested by superior.
The role includes leading, coordinating and performing, validation and calibration activities in the warehouse areas and distribution-- vehicles. Occasionally, early work hours are require.