Edwards Lifesciences Sr. Engineer, Supplier Quality in Anasco All Locs, Puerto Rico
Apply knowledge of supplier 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.
• Provides technical guidance and quality compliance for Supplier Quality engagement throughout the New Product Development (NPD) lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
• Ensures that suppliers deliver quality parts, materials, and services.
• Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
• Monitors parts from suppliers and communicates and resolves supplier-related problems as they occur.
• Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Define Receiving Inspection requirements as required and associated test method validation for all internal Test Methods.
• Facilitates risk management activities with suppliers
• Assesses nonconformance and leads closure of SCARs as needed
• Other incidental duties assigned by Leadership
Education and Experience:
Bachelor's Degree in Engineering or related field
Required 4 years of experience in Supplier Quality within medical device or pharma industry, or related experience.
• Demonstrated working knowledge of supplier controls, process validation, supplier and internal auditing, failure investigation techniques, statistical quality control, protocol/report preparation and non-conforming product controls
• Basic understanding of statistical techniques.
• Manufacturing Engineering and/or Process Validation background preferred
• Strong problem-solving, organizational, analytical and critical thinking skills
• Excellent verbal and written communication skills in English.
• Written and verbal communication skills in Spanish preferred
• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• 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 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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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.