Edwards Lifesciences Quality Engineer II in Cartago, Costa Rica
Supervises employees responsible for Quality Inspection.
• Supervise employees and quality activities pertaining to the production of products and/or manufacturing processes in - and with quality/technical knowledge of 2 or more production areas, depending on the complexity of the areas, in addition to conducting performance reviews, including resolving performance issues
• Develop and maintain sampling methods and procedures for inspections, testing and evaluation. It supports Quality Operations to guarantee that the products and processes comply with the relevant requirements of the Quality Management System
• Support activities related to the evaluation of product risks for non-compliant distributed products.
• Ensure that manufacturing processes are compliant with the quality systems requirements and apply engineering tools to ensure process are adequately controlled and collaborates with other departments in the resolution of issues and improvement activities.
• Develop and support ongoing improvement activities to improve 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.
• Partner with engineering on investigations and/or corrective actions, perform non-conformance investigations for review with engineering, assures documentation content is valid, may participate in improvement projects
• Oversee the scheduling of work orders and team performance metrics
• Ensure appropriate staffing for all positions
• Other incidental duties
Education and Experience:
Bachelor's Degree in Industrial Engineering, Business Administration or related field required, 2 years' experience with internship, or substantial technical knowledge and experience in assigned work area, and sufficient experience in related manufacturing, quality, medical device, pharmaceutical industry and/or product development engineering, with skill levels exceeding previous experience the requirements of the Supervisor I required and
previous related experience with full responsibility for all personnel including hire/fire authority and handling all aspects of employee relations in manufacturing, quality and/or product development engineering required
• Proven expertise in Microsoft Office Suite with working knowledge of Enterprise Resource Planning (ERP) system, preferably JDE
• Excellent communication and interpersonal relationship skills; possessing strong collaboration skills in partnering with cross functional stakeholders in order to achieve objectives
• Full understanding of quality procedures
• Ability to supervise/lead employees in a manufacturing environment with limited supervision
• Solid problem-solving, organizational, analytical and critical thinking skills
• Robust understanding of processes and equipment used in assigned work
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
• Ability to lead teams, provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Knowledge of Lean Manufacturing concepts and Six Sigma
• Participate on cross-functional teams Engineering, management, Regulatory, Manufacturing, HR, Planning for the development of cohesive production operations
• May represent the organization to outside contacts, e.g., vendors, suppliers, contractors, staffing agencies
• Good written and verbal English communication skills
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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
• Travel (day and overnight by car, air, train, etc.) will vary. Percentage of time is determined by Management
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 15,000 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.