Job Information
Edwards Lifesciences Senior Quality Management System (QMS) in Caesarea Granit, Israel
Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.
How you will make an impact:
Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes based on engineering principles; analyze results, make recommendations and develop reports
Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports and collaborate with team members to drive project completion
Lead in the identification and ensure the optimization of complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of more complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
Develop technical content of risk management files
Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work.
Train, coach, and guide lower level employees on more complex procedures
What you’ll need (Required):
Bachelor's Degree in Engineering or Scientific field
5 years of experience in Quality Management Systems
Certified auditor
What else we look for (Preferred):
American Association of Lab. Animal Sci. Cert. (AALAS) / ASQ Certified Quality Engineer (CQE)
Proven expertise in usage of MS Office Suite
Ability to read and interpret drawings
Proven expertise in statistical techniques
Excellent documentation and communication skills and interpersonal relationship skillsincluding negotiating and relationship management skills
Ability to translate technical information to all levels of the organizations
Extensive knowledge and understanding and knowledge of principles, theories, andconcepts relevant to Quality Engineering (e.g., CQE body of knowledge)
Knowledge of Six Sigma concepts with ability to apply to work product
Knowledge of Quality Engineering concepts with ability to apply to work product
Advanced problem-solving, organizational, analytical and critical thinking skills
Extensive understanding of processes and equipment used in assigned work
Strong leadership skills and ability to influence change
Knowledge of and adherence to Edwards Environmental Health and Safety and Qualityguidelines as they relate to department clean room medical device manufacturing
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Work is performed independently while exercising considerable latitude in makingsignificant decisions
Set policies and standards that are followed by others
Guides others in resolving basic issues in specialized area based on existing solutions and procedures
Must be able to work in a team environment, including frequent inter-organizational andoutside customer contacts
Represents organization in providing solutions to difficult technical issues associated with specific projects
Develops technical solutions to complex problems which require the regular use ofcreativity
Uses best practices and knowledge of internal or external business issues to improveproducts/services or processes
Typically resolves complex problems or problems where precedent may not exist
Adhere to all company rules and requirements (e.g., pandemic protocols, EnvironmentalHealth & Safety rules) and take adequate control measures in preventing injuries tothemselves and others as well as to the protection of environment and prevention ofpollution under their span of influence/control
Edwards Lifesciences
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