Sr Prin Engineer Qual

Overview

When you join the team at Cordis, you become part of an inspiring mission to save lives, impacting millions of people and broadening access to life-saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart of innovation to transform cardiovascular care.

At Cordis, we’re teammates, not just employees. We embrace an empowered and one-team culture where teammates are inspired to unleash their full potential. With diverse teams on a global scale, 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, transformative and positive impact on the lives of millions, then Cordis is just the place for you. We are the people behind the people who keep saving lives.

Ensures that the products meet strict safety and quality standards. Collaborates with design and production teams to establish and maintain quality control procedures. Analyze data to identify areas for improvement and implement corrective actions to enhance the overall product quality. The Quality Engineer works on problems and projects of moderate scope, using advanced analysis techniques to drive continuous improvement at pace. The position exercises judgment within defined procedures and practices to determine appropriate action and demonstrates full use and application of standard principles, theories, concepts, and techniques. The candidate must be able to accomplish broad and complex assignments and may provide technical guidance to lower-level personnel.

Responsibilities

• Ensure compliance with FDA, ISO 13485, and other regulatory standards by conducting inspections, audits, and risk management activities.
• Develop, implement, and maintain quality control procedures and documentation to uphold manufacturing excellence.
• Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.
• Plans and conducts work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria.
• Devises new approaches to problems encountered.
• Independently performs most assignments with instructions as to the general results expected.
• Receives technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects.
• Plans, schedules, conduct, and coordinates detailed phases of engineering work in part of a major project or in a total project of moderate scope.
• Performs work that involves conventional engineering practice but may include a variety of complex features such as conflicting design requirements, unsuitability of conventional materials, and difficult coordination requirements.
• Work requires broad knowledge of precedents in the specialty area and good knowledge of principles and practices of relates specialties.
• May technically supervise or coordinate the work of engineers, draftspersons, technicians, and others who assist in specific assignments.
• Practices company safety, quality policies and procedures, actively requires conformance.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.
• Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
  
  
  

Qualifications

• Requires Engineering Bachelors Degree and 8 years of experience or Master's Degree and 6 years of experience
• Basic knowledge of FDA and International Medical Device Quality System Regulations and ISO 13485
• Ability to comprehend principles of engineering, chemistry, polymers, physiology, and medical device use.
• Excellent oral and written communication skills
• Knowledge of techniques to drive improvements in processes and systems
• Strong computer skills (including Excel, PowerPoint, etc.)
• Lean Manufacturing and process validation experience is a plus.
• Effective interpersonal skills
  
  
  

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All our teammate’s points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.