Edwards Lifesciences Assoc Mgr, Quality in Haina, Dominican Republic
Descripción/ Role Purpose
Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
Develops solutions to complex problems, which require the regular use of ingenuity and innovation; ensures solutions are consistent with organization objectives. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Uses best practices and knowledge of internal or external business issues to establish process improvement goals for improved products/services or processes.
As a quality engineer, you are part of the continuous and value improvement of our product quality and quality management system. Ensure the company is positioned at all times as a key preferred supplier within the medical devices industry.
Collaborate in the process design and design transfer activities ensuring that adequate systems are properly validated and qualified to ensure to meet product requirements.
Promote multifunctional team approach and Edwards cultural beliefs while ensure that expected project output meet the Quality System requirements.
Supervise small team that support different plant and business strategies and projects.
May coordinate activities of others on projects assignment basis.
Responsible for leading multifunctional teams to develop the quality planning through risk assessment activities, creating and maintaining files including Process Map, FMEA and others applicable documents.
Supports process improvement plans and strategies that are designed to mitigate the risks identified through Risk Management process.
Work on product/process transfer activities to assure risk assessment is adequately executed to implement effective mitigation plans.
Enhance the Quality Systems, using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, SPC, Kaizen lean methods, DOE, etc.
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.
Comply with the standards, regulations, procedures and quality manuals applicable to Edwards Lifesciences.
Education / Experience
Bachelor's degree Science or engineering
8 years of experience applying knowledge of principles and concepts of Quality and Engineering in similar positions. Requires in-depth knowledge and experience of team. Experience in Quality Assurance for consumer product, quality management systems and quality system audits manufacturer.
Master's degree in related field with 6 years applying knowledge of principles and concepts of Quality and Engineering in similar positions.
Demonstrated experience working with contract manufacturers, suppliers, or distributors.
Demonstrated exceptional written and oral communication skills.
Proficiency in Microsoft Office.
Passion and alignment with our mission, vision, values & operating principles.
Passion for working in a values based company in alignment with a learning organization.
Demonstrates a passion and a responsibility for consumer.
Exhibit a passion for the company’s Essence, Global Imperatives, Corporate Direction.
Desire to own decisions and take responsibility for outcomes.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.