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:
• Investigate and develop action plans for complex manufacturing product quality and compliance issues (e.g., SCAR management, non-conformances, productivity, and audit observations) for all supplier processes based on engineering principles and Edwards quality standards.
• Own and coordinate supplier Notice of Change (NOC) requests. Manage supplier project plans, facilitate part qualification process, and ensure closure of any change plan deliverables.
• Monitor supplier performance and develop improvement plans to mitigate risk and supply chain disruptions. Activities include supporting Supplier Business Reviews, Scorecard management, Critical Control Point monitoring, and overall quality performance assessment.
• Identify and ensure the optimization of complex Manufacturing and/or R&D 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.
• Update, and maintain supplier file content including Supplier Management system administration, support Approved Supplier List (ASL) activities, and any required Preference Category status changes.
• Partner with Supplier Management to onboard new suppliers in alignment with each category strategy. Activities include developing and finalizing Quality Agreements, supporting Technical Assessment, Supplier Management system administration (SQMS), and conducting the initial qualification audits.
• Support the Quality Audit program for all identified suppliers (Surveillance, Qualification, Performance). Supplier Quality Engineers will conduct the Quality Audit, drive corrective actions, and ensure closure of any findings.
• Support Edwards sites in their Receive on Certification program owning supplier agreements, SPC data reviews, and process audits, where appropriate.
• Train, coach, and guide lower level employees on routine procedures.
• Other incidental duties assigned by Leadership.
What you'll need (Required):
Bachelor's Degree in Engineering or Scientific field, 4 years experience Required or
Master's Degree or equivalent in Engineering or Scientific field, 3 years experience Required or
Ph.D. or equivalent in Engineering or Scientific field, 0 years experience Required
What else we look for (Preferred):
• Proven expertise in usage of MS Office Suite; CAD experience preferred
• 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
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Strong problem-solving, organizational, analytical and critical thinking skills
• Substantial understanding of processes and equipment used in assigned work
• Good leadership skills and ability to influence change
• Knowledge of and adherence to Quality systems
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• 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
