Job Summary: Analyzes and provides direction to engineering and manufacturing teams regarding requests for changes to product configuration documentation, ensuring compliance and providing support. Key Highlights: 1. Direct and transformative impact on the lives of millions of people 2. Empowered, one-team culture 3. Support for CAPA investigations and approvals The Big Picture: When you join the Cordis team, you become part of an inspiring mission to save lives, impact millions of people, and expand access to life-saving cardiovascular and endovascular technology. As a global leader for more than 60 years, we are committed to being the heart of innovation to transform cardiovascular care. At Cordis, we are teammates—not just employees. We embrace an empowered, one-team culture where teammates are inspired to unlock their full potential. With diverse teams across the globe, we believe the richness of our experiences and backgrounds enhances our teammates’ careers, service to our customers, and ultimately, the lives of our patients. If you love challenges and are ready to make a direct, transformative, and positive impact on the lives of millions of people, then Cordis is the perfect place for you. We are the people behind the people who continue to save lives. Responsibilities: Analyzes and provides direction to engineering and manufacturing teams regarding requests for changes to product configuration documentation (drawings, specifications, qualified and non-qualified bill of materials, route sheets, etc.) to ensure compliance with regulations, business processes, and procedures. Provides training and assistance for product configuration in the Product Management system. Monitors (manual and electronic) product configuration changes to verify structural correctness. Performs a variety of routine tasks designed to build experience and familiarity with engineering equipment, methods, practices, and programs. Provides support for CAPA investigations and documentation. *ESSENTIAL DUTIES AND RESPONSIBILITIES:* * Collects basic information and data required to analyze a problem or situation using appropriate tools, capable of generating suggestions and potential solutions with minimal supervision, communicating effectively throughout the process * Analyzes and provides direction, training, and assistance to engineering and manufacturing teams regarding requests for changes to product configuration documentation (drawings, specifications, qualified and non-qualified bill of materials, route sheets, etc.) * Monitors (manual and electronic) product configuration changes to verify structural correctness and updates information in engineering, manufacturing, product management, control, and business planning systems based on approved changes. * Performs a variety of routine tasks designed to build experience and familiarity with engineering equipment, methods, practices, and programs. * Reviews and interprets documents such as preliminary designs, drawings, change orders, specifications, etc. to verify completeness and accuracy of data. * Resolves technical issues related to quality systems supporting manufacturing processes Receives general direction on assignments that may include but are not limited to: specification preparation, process studies, investigation, report preparation * Participates in verification and validation of systems supporting manufacturing processes. * Possesses basic knowledge of functional area processes and systems, taking advantage of opportunities to continue acquiring and developing expertise. * Is able to work with personnel from different functional areas, clearly communicate key principles of systems supporting manufacturing processes, and collaborate in teams to develop basic business solutions. Capable of applying basic risk assessment principles in solution development. * Seeks to learn from past experiences and helps others apply lessons learned to solve problems. * Supports CAPA investigations and approvals. * Tracks CAPA and Change Control metrics. * Performs CAPA Coordinator functions for the site. * Training department-related activities such as task reviews, training assessments, and myLearningLMS account follow-up. * Performs any other quality systems-related tasks as required. * Collaborates with other sites to provide necessary support related to CAPA, Change Control, and training. Qualifications: Completed Engineering degree or Bachelor’s degree (preferably in Systems, Computer Science, or Industrial Engineering) 0–2 years of experience Preferred Qualifications: *KNOWLEDGE, SKILLS, ABILITIES, AND CERTIFICATIONS REQUIREMENTS 1 LICENSES:* Proficiency with personal computers and related applications (Word, Excel, PowerPoint) Hardware proficiency (printer, PC) Departmental leadership and direction In-depth knowledge of configuration management in Engineering and Manufacturing areas; understanding of production and quality techniques (WIP, JIT, SPC, etc.) Knowledge of Quality System Regulations (QSRs) and other industry regulations/standards. Extensive knowledge of company products and manufacturing processes. Ability to communicate in English (oral and written) *ADDITIONAL POSITION REQUIREMENTS:* Includes additional requirements if the position requires working in a "clean room," with heavy machinery, or physical capability