דרושים בתחום תפקידים נוספים

As the Quality Management System (QMS) Specialist you will be responsible for leading and executing activities related to procedural document development and training.


A Day in the Life
Duties and responsibilities may include, but are not limited to:
· Coordinates the site procedures and work instructions routing, review, approval, distribution and maintenance.
· Supports in preparation for Management reviews, internal and external audits .
· Serves as a point of contact for the site employees in accessing/inquiring controlled documents.
· Maps out annual QMS training plan, conducting organization-wide training needs assessment and identification of skills or knowledge gaps that need to be addressed.
· Defines and maintains employees’ competence according to QMS requirements.
· Maintains training database and records.
· Evaluates training effectiveness and determines the impact of training on employee skills.
· Monitors Key Process Indicators (KPIs)
· Organizes and maintains quality documents and records and tracks the document status.
· Other duties may be assinged.

Must Haves
· Bachelor’s or practical engineer degree, preferably in a technical or scientific discipline.
· 1-2 years of quality assurance/document control/training in medical device or pharmaceutical industry
· Basic knowledge of computer systems and commonly used software applications is mandatory.
· High verbal and written communication skills (Hebrew and English)

Nice to Haves
· Experience managing manual and electronic document management systems in a regulated pharmaceutical/medical device environment is preferred
· Quality assurance certifications and courses
· Understanding and knowledge of relevant regulations and standards FDA QSR, ISO 13485, MDD is preferred