Site Quality Head, Tel Aviv Israel

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Head, QA Israel (Site Quality Head)

The Head of QA has the overall responsibility for Quality Assurance aspects of Manufacturing, products and technologies reporting to Frédéric Yannart - Sr Director Quality EMEA&APAC

Key Responsibilities:

• Ensuring the QMS is implemented, maintained and continually improved
• Responsible for the management (implementation, maintenance, and improvement) of the Quality Management System
• Promoting awareness of customer requirements, applicable regulatory requirements and quality management system requirements and assuring that those requirements are understood throughout the Cheetah Medical organization
• Achieve and maintain ISO 13485, MDSAP, MDR and other required Quality Management System certifications
• Maintaining GMP compliance status, per the applicable regulations, coordinating communication with external parties on matters relating to the QMS registration
• Reporting to top management on the performance of the quality system, including new needs for improvement and resources
• Fulfilling the role of Management Representative for product conformance to applicable standards and regulatory requirements
• Responsible for final decisions related to products’ conformance and release
• Approving or rejecting products manufactured, processed, packed, or held under contract by another company
• Initiating the Field Actions process and approving the final Field Action decision and being responsible for Quality Control testing, providing adequate laboratory facilities for the testing, approving or rejecting components, containers, closures, in-process materials, packaging material, labeling, and final products
• Responsible for quality approval of design and manufacturing changes, approving or rejecting procedures, processes or specifications impacting the QMS, quality and performance of the product
• Ensuring that regulated activities, not directly managed by the quality unit, are controlled by appropriate quality processes
• Collaborating with the broader Baxter QA community and maintaining the Management Review process for their entity
• Providing guidance to the R&D teams on quality standards and expectations
  
  

• QA/QC Personnel recruitment
• Approval of annual plans: Training, Internal Audits, etc.
• MRB, NCR, CAPA, Change Control approval
• Design Review approval
• Management Review meeting report approval
• Has the authority to hold or resume production and/or sales due to regulatory or quality reason.
  
  

• Effectively prepare, represent and communicate with Regulatory Agencies during audits
• Detail oriented strong interpersonal, communication, writing, and organizational skills required to effectively work in a quality/regulatory and project team environment
• Strong analytical and mathematical skills are required to interpret and analyze scientific test data for quality systems functions and regulatory submissions
• Strong leadership and program management experience
• Good computer skills (Word processing, spreadsheets, graphics, internet)
• Thorough knowledge of regulatory requirements pertaining to FDA/QSR, ISO 13485, MDSAP, MDR and other markets requirements
• Bachelor's degree or equivalent experience in an engineering and/or scientific orientation field
• More than 10 years' experience in the Medical Device / Pharmaceutical Industry Quality Assurance
• Experience of routine QA/QC activities such as: CAPA, MRB, ECO, RMA, SCAR
• Proven leadership skills; ability to prioritize, plan, evaluate & complete results for established tactical goals
• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.
• Excellent communication skills to collaborate with all levels of company structure as well as represent company to outside agencies.
• English Proficiency, excellent verbal, written, and presentation interpersonal skills.
• Readiness Business trips A few times a year