Job Description
Las Visión de Conjunto About Us:Cordis is an independent, customer-focused global provider of interventional cardiovascular medical technologies. During our 60+ year history we’ve established a legacy of pioneering breakthrough technologies, including the first guiding catheters and coronary drug eluting stents. Cordis has built a strong global footprint that spans over 70 countries.We’re teammates, not just employees. Our culture empowers you to act like an owner and unleash your full potential in the process. With diverse teams on a global scale, we foster an inclusive atmosphere where everyone is embraced for who they are, their unique perspective, and what they bring to the table. We believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients.If you love a challenge and are ready to have a direct, positive impact on the lives of millions, then Cordis is just the place for you. Join us, and let’s improve the wellbeing of millions, together.We are the people behind the people who keep saving lives.The Sr Principal Quality Engineer (PAL) is responsible for performing investigations related to customer complaints on the product returned for analysis to detect possible root causes on the failures. Execute problem solving skills during investigations with the intention of identifying root causes and corrective and preventive actions related to the issues analyzed. Ranks, prioritizes and accurately manages different aspects of complaints as required by company and local/international government regulations. Analyze departmental issues and work with improvement projects related to cost reduction, and process improvement or compliance improvement. Responsabilidades May be responsible for assigning product complaint files and complaint activities to the appropriate product complaint analysts and PAL personnel as appropriate. Investigate and processes product complaints, while maintaining compliance to all regulations Performs/Document Product Evaluations properly and following GDP’s. Maintain communication with engineering teams in order to conduct a deep dive on complaints that may be related to a manufacturing and/or design issue. Perform measuring, testing and analysis on the returned devices to determine the possible root causes of the issues reported. (e.g. dimensional inspection with ruler, caliper, laser micrometer, etc.; also, perform functional testing by using pull testers, leak testers, and other equipment, as required) Document the investigation in the applicable Global Complaint Handling System, following Cordis policies and procedures, and applicable regulations. May be required to perform specialized studies such SEM analysis, X-Ray analysis, and others analysis, as applicable. Comply with internal departmental metrics and with the Complaint Handling and Safety Surveillance departmental metrics. Address investigations to document Audit Observations, CAPA Actions, non-conformances, and any other investigation, as applicable. Maintain appropriate level of knowledge on products and processes manufactured by the company and OEM’s as required. Escalate potential manufacturing and design related issues properly and in a timely manner. Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance. Work with complex projects to support improvement activities in the department. Provide guidance to the other team members, as required. May be responsible to complete validation activities related to laboratory equipment. Calificaciones Bachelor’s degree in related field is required. 10+ years experience Experience in the medical device industry is an asset. Experience in leading a team is preferred Excellent written and oral English communication skills Problem Solving Skills is required. Computer literate in MS Word, MS PowerPoint, MS Excel a plus Ability to interact with individual/groups at all levels Ability to identify priorities and function independently Ability to present information to upper management. Ability to work with complex projects. Quality Auditor/Quality Engineer certification is desirable (CQA/CQE) Analytical thinking Measurement systems knowledge. Position requires to work in a laboratory environmental. Position requires to be enrolled in a medical vigilance program