לוח משרות דרושים מנהל איכות | מנהל QA

The job holder’s duties and responsibilities include any of the following:
* Act as Insightec Quality Management Representative
* Responsible for the Insightec quality management system
* Lead the Quality Assurance team
* Lead the company to meet its annual quality goals
* Lead quality data analysis
* Update company management on quality performance and policy implementation
* Define and maintain quality aspects processes for relevant quality related Insightec activities
* Lead and ensure company compliance with quality standards and certifications as required
* Lead and prepare the company for internal and external auditing authorities as required
* Support company teams with QA requirements and processes
* Act as the person responsible for regulatory compliance (PRRC)

Advantages::

* Formal Auditing Conductance training

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.

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