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. Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, nonconformance, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. Identify 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 basic equipment, tools, fixtures, etc. to improve manufacturing processes and reduce risk. Develop, update, and maintain 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. Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work. Train, coach, and guide lower level employees on routine procedures. Proven expertise in Microsoft Office Suite, JDE (or other Enterprise Resource Planning system) Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills. Working knowledge and understanding of statistical techniques. Previous experience working with lab/industrial equipment required. Ensure proper handling, storage and disposal of all waste generated in the facility according to applicable laws within the waste management program (RCRA). Prepare regulatory and/or internal reports, complete waste determinations, sign waste manifests and coordinate proper training sessions to affected personnel. Qualifications: Education/Experience: Bachelor's Degree or equivalent in Engineering or Scientific field with 4 years minimum of experience in industry/education related; or Master's Degree or equivalent in Engineering or Scientific field with 3 years minimum of experience in the industry/education related; or Ph.D. in Engineering or Scientific field with no experience. Certified Quality Engineer (CQE) preferred. About Edwards 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. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Title: Sr Engr, Quality Location: Puerto Rico-Puerto Rico Job Number: 019983 Associated topics: ehs, environmental, environmental impact assessment, geotechnical, green energy, hazardous material, waste, waste management, wastewater, water
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