Quality Coordinator - Yokneam, Israel

Title: Quality Coordinator

Israel- Yokneam

We have an exciting opportunity for a full-time Quality Coordinator to join our growing team!  Reporting to the QA  Director. The Quality Coordinator will be based in Israel- Yokneam and will responsible for all the QA procedures.

DUTIES & ESSENTIAL JOB FUNCTIONS

1. The Medical Device Quality Assurance Specialist supports and reviews quality Involvement, responsible for timely support of cross-functional projects and guiding the product development from concept onward, including determination of necessary testing and validations according to relevant standards.
2. improve Quality systems processes and serves to improve awareness, visibility, and communication.
3. Preforming quality initiatives to support assigned quality goals and priorities.
4. Reports to QA Manager / Management to create new Quality System procedures/instructions
5. Monitor and maintenance of existing processes.
6. Assist in preparation for internal and external audit.
7. Assist in creating and maintaining internal audit schedules and records including tracking CAPA activities as required
8. Assist in and prepare for the execution of Notified Body audits and track progress of
   Assist in investigating quality issues and interact with products suppliers regarding these
9. Review and investigate customer complaints, determine product failure root causes and evaluate risk of failures.
10. Ensure that the quality system is understood and applied throughout the organization on all levels by personnel concerned Authorizing product release to stock and completion of relevant records upon receipt.
11. Assisting in maintenance of technical files, OBL files and test reports of product conformity
12. according to MDD \MDR and FDA.

 REQUIRED

1. Knowledge of quality systems (ISO 13485), associated documentation
2. Knowledge of medical device industry and medical device regulations (MDD,21CFR 820 & MDR
3. including pertinent standards and guidance's
4. Bachelor’s degree in biological sciences, engineering, or related field.
5. At least 2-3 years’ experience working in a regulated environment
6. Be aware of the latest medical device regulation
7. Very proficient in attention to detail
8. Ability to work and communicate with others in a professional and effective manner,
9. within a team-oriented environment
10. Knowledge of Microsoft Office including Excel, with an ability to learn other computer based systems.
11. Ability to work in collaborative and independent work situations
12. Ability to remain calm and receptive in fast paced situations
13. Hands on, motivated, decisive, roll-up-your-sleeves approach
14. Highly proficient verbal and written communication skills in English
15. accountability and responsibility

 What you will be part of – our Venus Concept Culture

Venus Concept believes in pushing boundaries while embracing creativity and innovation. Our employees are a critical part of our company’s performance and are at the core of its success. At Venus Concept, we rely on our employees, customers, and network of industry professionals around the world to continuously improve and Deliver the Promise. In order to do that, we ensure that everyone operates with the same values and vision.  At Venus Concept, we promise to give you Endless Opportunities, allow you to Foster Innovation and be part of Delivering a Best-In-Class Offering.

Venus Concept is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. Venus Concept is committed to accommodating persons with disabilities. Accommodations are available on request for qualified candidates during each stage of the recruitment process.

About Venus Concept

Venus Concept is an innovative global medical aesthetic technology leader with a broad product portfolio of minimally invasive and non-invasive medical aesthetic and hair restoration technologies and reach in over 60 countries and 21 direct markets. Venus Concept focuses its product sales strategy on a subscription-based business model in North America and in its well-established direct global markets. Venus Concept’s product portfolio consists of aesthetic device platforms, including Venus Versa, Venus Legacy, Venus Velocity, Venus Fiore, Venus Viva, Venus Freeze Plus, Venus Heal, Venus Glow, Venus Bliss, Venus Epileve and Venus Viva MD. Venus Concept’s hair restoration systems includes NeoGraft®, an automated hair restoration system that facilitates the harvesting of follicles during a FUE process and the ARTAS® and ARTAS iX® Robotic Hair Restoration systems, which harvest follicular units directly from the scalp and create recipient implant sites using proprietary algorithms. Venus Concept has been backed by leading healthcare industry growth equity investors including EW Healthcare Partners (formerly Essex Woodlands), HealthQuest Capital, Longitude Capital Management, and Aperture Venture Partners. For more information, please visit www.venusconcept.com