Engineer I Quality (Onsite)

Cordis; Town of Florida (NY); On-site; USD 85,000 - 120,000; Full time

Job summary

Cordis is seeking a Quality Assurance professional to ensure products meet safety and quality standards, collaborating with design and production teams to maintain quality control. You will analyze data, implement corrective actions, and support regulatory compliance in a fast-paced medical device environment.

Successful candidates will have an engineering degree, exposure to FDA/ISO13485, and strong communication skills to drive improvements across processes and teams.

Qualifications

• Requires Engineering Bachelor’s Degree.
• Preference for internship in Medical Device Manufacturing or regulated environments.
• Knowledge of FDA and ISO 13485 quality systems.
• Strong communication, problem-solving and teamwork abilities.

Responsibilities

• 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.
• Root cause analysis and corrective actions for quality issues.
• Develop and maintain quality control procedures and documentation.
• Monitor and analyze data related to product quality and identify trends.
• Support validation of manufacturing processes to meet quality requirements.
• Participate in risk management and mitigation of quality risks.
• Contribute to validation protocols for equipment and processes with guidance.
• Assist in investigation of customer complaints and non-conformities, implementing actions.
• Perform supplier quality assessments and collaborate with suppliers to improve quality.
• Ensure regulatory compliance with FDA and other standards.

Education

Engineering Bachelor’s Degree

Job description

OverviewWhen 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.

OverviewWhen 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.
ResponsibilitiesEnsures 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.
Job Responsibilities

• 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.
• Working under the guidance of others to 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 with guidance from others.
• 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.
• Collaborate with the manufacturing team to continuously improve processes and enhance overall product quality.
• 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.
• Responsible for communicating business-related issues or opportunities to next management level
• Stay updated on industry trends, regulations, and best practices to ensure the application of current quality standards in the medical device field.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets
• Performs other duties assigned as needed

QualificationsRequired Qualifications

Preferred QualificationsRequires Engineering Bachelors Degree. No relevant experience required.

• Medical Device Manufacturing or other regulated industry Internship preferred.
• 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.

Knowledge/Skills And/or Experience

• Excellent oral and written communication skills
• Knowledge of techniques to drive improvements in processes and systems
• Effective interpersonal skills

While performing the duties of this job, the employee occasionally works near moving mechanical parts and is occasionally exposed to risk of electrical shock. May be required to work in a clean‑room environment.
The noise level in the work environment is usually moderate.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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.