Supplier Quality Manager

Biosense Webster R&D Haifa Technology Center (HTC) is located in Yokneam, Israel. The HTC teams partner with leading physicians from around the globe to develop innovative MedTech solutions that improve the quality of care for patients worldwide.

The company's work is built on a proud legacy of leadership in electrophysiology. What began in the 1990’s with the founding of Biosense has evolved to present-day expertise driving best-in-class solutions in cardiac ablation, stroke care, intracardiac imaging and navigated ENT surgery.

Innovation is at the forefront at the Haifa Technology Center. HTC has been the top patent applicant in Israel for a decade. To fuel its innovation, experts in systems engineering, software integration, image integration, ultrasound capabilities, 3D printing and miniature sensors work collaboratively to create solutions that improve physician workflow and patient outcomes. HTC is also embracing the future of patient care by pioneering next-generation digital solutions, such as cloud-based applications that are powered by artificial intelligence.

A culture of continuous learning gives HTC employees fresh perspective to fuel continuous innovation and growth. The company embraces the unique perspectives, backgrounds and ideas of its employees, and provides them a fascinating career path and an opportunity to impact patients' lives.

We are looking for a Supplier Quality Manager Quality LCM to join our team!

This role leads/manages the Supplier Quality Management /Purchasing Control process and ensures that HTC Suppliers provide purchased finished goods, direct and indirect materials, or services in compliance with CSS and J&J policies/procedures, Global Regulations and industry standards.

Responsible for supplier oversight from qualifying new suppliers, monitoring and improving supplier’s performance

Duties and Responsibilities:

Serves/provides management oversight focusing on Purchasing Controls/Supplier Quality Management for assigned supplier categories globally.
Leads/participates in the external supply selection process to provide quality system expertise.
Develops and deploys strategies to effectively manage direct and indirect Suppliers with appropriate risk-based controls.
Compiles and recommends data driven conclusions for Management Review
Analyzes quality data and identifies trends impacting risks/benefits requirements of process, Product, and quality systems with primary responsibility for the development and maintenance of HTC external suppliers.
Utilizes key knowledge of business processes, analytical tools, and the regulatory environment to support the supplier quality management lifecycle.
Leads/assists in the maintenance of the supplier quality relationship (proactive quality reviews, risk-sensing modeling, follow-up on corrective actions, metrics development/improvements, etc.)
Ensures compliance to applicable Global Regulations and standards (e.g. QSR, ISO, EN, Medical Device Directive (MDD), and EU MDR requirements)
Team development, Mentor and trains team members.
Qualifications
BSc in Engineering or Practical Engineering with Qualification in Quality Assurance (CQE, CQM or CQA) .
At least 5 years of experience as a quality leader in a WW manufacturing organization (preferably, Medical Devices Industry)
Practical knowledge of ISO13485 , Experience in the Medical Device industry or medical field
Demonstrated knowledge of manufacturing principles and practices, and procedures
Demonstrated knowledge of Statistical Analysis Tools
Must be a self-starter/able to think outside the box, challenge the norm and drive change.
Ability to collaborate and build strong partnerships internally/externally with customer focus.
Must have excellent communication, interpersonal and presentation skills (Also in English)
Significant teamwork and leadership skills
Demonstrate project management skills with strong results orientation.
Self-confidence and integrity
Builds relationships based on respect, listens to and incorporates diverse points of view.

#LI-AB6

#LI-Hybrid