QMS Lead

Reporting to the Head of QA/RA, the QMS Lead manages quality management system activities according to the quality policy and quality objectives.
QMS Lead will assist QA/RA Director in managing QMS activities and in identifying and implementing quality system improvements, specifically for elements related to product quality and regulatory compliance.
As the QMS Lead, you will maintain and develop the companies QMS systems, and assisting with internal and external audits. You will also be working with the quality operation manager, to ensure the company is operating smoothly.
Provide data and present compliance information during Joint Quality Review.
Monitor, analyze and report of compliance data.
Alert organization to existing and potential problems and risks.
Collaborate with functional department to establish effective corrective and preventive actions. Communicate, educate, and facilitate implementation of changes to external Standards and Regulation across QMS.
QMS leader must develop strategic QMS standards, procedures, programs, initiatives, and targets to ensure required quality performance and regulatory compliance is achieved.
Responsibilities:
Promote Good Manufacturing Practices.
Overseas that quality assurance objective maintained.
Assures compliance to in-house and external specifications and standards.
Participate in second- and first-party audits.
You will play a fundamental part in managing and developing the company training matrix and will be responsible for Ensure quality agreements and quality questionnaires are in place with external companies.
Develop, follow, and review internal and external policies, procedures, and documentation for the carrying out audits.
Responsible for ensuring that staff adhere to their KPI’s, as well as internal and quality assurance standards.
Ensure all staff have a clear understanding of their measurable Targets / KPI’s and have a clear understanding of the company’s strategic objectives and vision.
Competencies:
Good working knowledge of medical device Quality System Regulations (21 CFR 820), ISO 13485 and MDD/MDR requirements.
Excellent writing skills with ability to write quality assurance reports and detailed procedures. Good presentation skills. Good interpersonal skills to interact with all levels of the company.
Knowledge in audit principles, procedures, and methods.
Experience in managing the audit process to achieve the defined audit objectives.
Ethical, truthful, sincere, honest, and discreet personality.
Attention to Quality & Detail, Decision Making & Problem Solving
Leadership, teamwork, and flexibility.
Education / Experience / Skills:
A diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, life-science, medicine, pharmacy, engineering, or another relevant discipline.
Knowledge in the field of medical devices and at least 5 years of professional experience in QMS and regulatory affairs of medical devices.
At least-5 years of management experience.
Able to communicate at all organizational levels.
Must have excellent reading, writing and communication skills in English and Hebrew.
Excellent reporting, teamwork, and time management skills
Ability to learn quickly, analyze problems, work independently, and organize and execute multiple work tasks.