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