Quality Engineer

Overview:

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 Quality Engineer II 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. Provides and develops solutions to problems of limited scope. Must be capable of execution on broad and complex assignments with support and mentoring from others.

Responsibilities:

• Responsible for quality planning, evaluation, and control. Works cross-functionally in the development and implementation of prevention-based methodologies used in design, manufacture, test, sustainability and correction of products.
• Demonstrates understanding of quality philosophies, principles, systems, methods, tools, and standards.
• Perform inspections and audits of manufacturing processes to ensure compliance with quality standards and regulations.
• Collaborate with cross-functional teams to create, review and approve manufacturing documents.
• Conduct root cause analysis and implement corrective and preventive actions for quality issues.
• Assist in the development and maintenance of quality control procedures and documentation.
• Monitor and analyze data related to product quality, identifying trends and areas for improvement.
• Support the implementation and validation of manufacturing processes to meet quality requirements.
• Participate in risk management activities, including the identification and mitigation of potential quality risks.
• Contribute to the creation and execution of validation protocols for equipment and processes.
• Assist in the investigation of customer complaints and non-conformities, implementing corrective actions as needed.
• Perform supplier quality assessments and collaborate with suppliers to improve product quality.
• Support regulatory compliance by ensuring adherence to FDA and other relevant standards.
• Conduct internal and external quality system audits to verify compliance with quality management systems.
• Participate in the development and delivery of training programs related to quality standards and procedures.
• Collaborate with the operations team to continuously improve processes and enhance overall product quality.
• Acquires and analyzes data using appropriate standard quantitative methods to facilitate process analysis and improvements.
• Assist in the preparation and reporting of quality metrics during operations and quality review presentations at defined intervals.
• Review and approve complaint, CAPA, NCs, Supplier CAPAs, and Audit Observation investigations.
• Ensure Site Metrics are complying with internal requirements and goals established.

Qualifications:

• Bachelor’s Degree in Technical discipline and a minimum of 2+ years of experience preferred, in the medical device/pharmaceutical field, or equivalent combination of education and experience.
• Expertise in the FDA and International Medical Device Quality System Regulations and ISO 13485
• Six Sigma, Lean and/or CQE certification is a benefit
• Ability to comprehend principles of engineering, chemistry, polymers, physiology, and medical device use
• Excellent oral and written communication skills
• Proven ability to create improvements in processes and systems
• 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.