Cordis ยท 5 months ago
Quality Engineer II (Onsite)
Santa Clara, California
Full-time
Onsite
Mid Level
3+ years expCordis is a global leader dedicated to transforming cardiovascular care and saving lives. The Quality Engineer II will ensure that products meet strict safety and quality standards by collaborating with design and production teams, performing inspections, and implementing corrective actions to enhance product quality.
Health CareHealth DiagnosticsMedical
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
Qualification
Required
Requires Engineering Bachelors Degree
3+ years of relevant experience
Company
Cordis
Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease.
1001-5000 employees
H1B Sponsorship
Cordis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (3)
2023 (3)
2022 (4)
Funding
Current Stage
Late StageTotal Funding
unknown2021-03-12Acquired
Leadership Team
Scott Drake
Chief Executive Officer
Recent News
2025-11-11
TeamBest Global Companies
2025-11-07
News-Medical.Net
2025-11-01
Company data provided by crunchbase