This Quality Documentation & Training Coordinator is responsible for implementation and execution of documentation, change control, and training processes based on business, regulatory and customer requirements to ensure compliance with company and regulatory requirements.
This role will be based in Haifa following our planned office relocation in 2026.
Duties & Responsibilities
Initiates and executes an effective and efficient change control process in accordance to internal procedures
Lead, facilitate, and mentor teams through all stages of the change control and training process
Leads and participates in quality system improvement initiatives
Interface between functions /departments such as Design, Quality and Operations in product, process, system, or supplier related changes
Have responsibility for initiation of changes, assessment of the change impact and routing of all tasks, with attention to detail, for completeness, accuracy, effectivity and appropriateness
Liaise with Change Requester and SMEs during all stages of the Change Control process, including Training process
Reviews all changes for ensuring sound rationale, challenging justification, correct approval, alignment and oversight
Monitoring completion of post release tasks to ensure completion in a timely manner
Support and lead initiatives for continuous improvement
Participate in project teams for change control
Support in training needs related to the change control process
Manages periodic review process and procedures in applicable PLM Systems.
Support in the preparation, participate, and address issues related to document and change management for internal and external (FDA, BSI, etc.) audits as needed
Investigates and resolves non-conformances, audit observations, corrective and preventive actions (CAPAs) related to Change control and training process
Assists in the creation and development of metrics to evaluate the effectiveness and efficiency of Change Control Processes
May support onboarding training for new employees; collaborate with managers to align onboarding content with role-specific needs.
Monitor training completion, generate compliance reports, and collaborate with stakeholders to ensure compliance.
Performs other duties assigned as needed.
This role will be based in Haifa following our planned office relocation in 2026.
Duties & Responsibilities
Initiates and executes an effective and efficient change control process in accordance to internal procedures
Lead, facilitate, and mentor teams through all stages of the change control and training process
Leads and participates in quality system improvement initiatives
Interface between functions /departments such as Design, Quality and Operations in product, process, system, or supplier related changes
Have responsibility for initiation of changes, assessment of the change impact and routing of all tasks, with attention to detail, for completeness, accuracy, effectivity and appropriateness
Liaise with Change Requester and SMEs during all stages of the Change Control process, including Training process
Reviews all changes for ensuring sound rationale, challenging justification, correct approval, alignment and oversight
Monitoring completion of post release tasks to ensure completion in a timely manner
Support and lead initiatives for continuous improvement
Participate in project teams for change control
Support in training needs related to the change control process
Manages periodic review process and procedures in applicable PLM Systems.
Support in the preparation, participate, and address issues related to document and change management for internal and external (FDA, BSI, etc.) audits as needed
Investigates and resolves non-conformances, audit observations, corrective and preventive actions (CAPAs) related to Change control and training process
Assists in the creation and development of metrics to evaluate the effectiveness and efficiency of Change Control Processes
May support onboarding training for new employees; collaborate with managers to align onboarding content with role-specific needs.
Monitor training completion, generate compliance reports, and collaborate with stakeholders to ensure compliance.
Performs other duties assigned as needed.
Requirements:
EXPERIENCE AND EDUCATION
3+ Years of related work experience, including experience in Quality Systems, Information Technology for a Medical Device or a highly regulated organization
3+ years of experience in document management or using an electronic document management system
Experience working with business applications, not limited to GxP computer applications, such as Agile, TrackWise, is preferred
Proficient in Microsoft Office Applications, Adobe Acrobat, and database application
Fluent in Hebrew and English
Preferred
University/Bachelors Degree or Equivalent in Science/Engineering or Business Administration.
CQA/CQE certification from the American Society for Quality (ASQ)
Solid interpersonal skills
Solid analytical and problem-solving skills
Solid communications skills
Process and Detail oriented and focus in accuracy
Ability to work in a fast-paced environment and rapidly shifting priorities,
Ability to quickly adapt and navigate different applications and computer software
Solid presentation skills
Ability to communicate with multiple levels of management.
EXPERIENCE AND EDUCATION
3+ Years of related work experience, including experience in Quality Systems, Information Technology for a Medical Device or a highly regulated organization
3+ years of experience in document management or using an electronic document management system
Experience working with business applications, not limited to GxP computer applications, such as Agile, TrackWise, is preferred
Proficient in Microsoft Office Applications, Adobe Acrobat, and database application
Fluent in Hebrew and English
Preferred
University/Bachelors Degree or Equivalent in Science/Engineering or Business Administration.
CQA/CQE certification from the American Society for Quality (ASQ)
Solid interpersonal skills
Solid analytical and problem-solving skills
Solid communications skills
Process and Detail oriented and focus in accuracy
Ability to work in a fast-paced environment and rapidly shifting priorities,
Ability to quickly adapt and navigate different applications and computer software
Solid presentation skills
Ability to communicate with multiple levels of management.
This position is open to all candidates.
