Quality Engineer II (Onsite)

New Yesterday

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.
Responsibilities
SUMMARY
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.
ESSENTIAL DUTIES AND 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
Required Qualifications
Requires Engineering Bachelors Degree and 3+ years of relevant experience.
Preferred Qualifications
Medical device/pharmaceutical field, or equivalent combination of education and experience preferred
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.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES
Excellent oral and written communication skills
Proven ability to create improvements in processes and systems
Effective interpersonal skills
Pay / Compensation
The expected pre-tax pay rate for this position is $69,500 - $100,000 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.
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.
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Job Locations US-CA-Santa Clara
ID 2025-9295
Category Quality/Regulatory
Position Type Regular Full-Time
CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact GlobalHR@Cordis.com
Apply
Location:
Santa Clara
Job Type:
FullTime

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