Cordis · 3 months ago
Senior Engineer, Quality Manufacturing (Second Shift)
Irvine, California
Full-time
Onsite
Senior Level
5+ years expCordis is a company specializing in the development of advanced drug device combination products for treating coronary and peripheral artery disease. The Senior Engineer, Quality Manufacturing will ensure that medical devices meet quality standards throughout the manufacturing process, manage quality programs, and collaborate with cross-functional teams to drive process improvements.
Health CareHealth DiagnosticsMedical
Responsibilities
Provide on-the-floor quality engineering support to production teams, ensuring real-time issue resolution
Develop, review, and approve inspection and test plans, sampling methods, and control plans
Continuously identify and implement process improvements to enhance product quality, reduce waste, and optimize manufacturing efficiency
Conduct risk assessments related to manufacturing processes and identify potential areas for risk mitigation to ensure the safety and efficacy of medical devices
Stay up to date with regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that manufacturing processes adhere to these regulations
Work closely with suppliers to assess and improve the quality of incoming components and materials, fostering strong supplier relationships
Investigate and resolve quality issues by performing root cause analysis and implementing corrective and preventive actions
Maintain accurate and complete documentation of quality-related processes, inspections, and testing, ensuring compliance with Good Manufacturing Practices (GMP)
Provide training to manufacturing personnel on quality-related procedures, standards, and best practices
Support internal and external audits, including FDA inspections, by providing documentation, data, and expertise related to manufacturing quality
Support and coordinate product testing, equipment qualifications, validation and verification processes to ensure required specifications are met
Mentor and provide technical guidance to junior engineers, fostering their professional growth and development within the organization
Participate in the creation and execution of intellectual property strategies, including the drafting and filing of patent applications
Qualification
Required
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related Engineering field
5+ years in medical device production development
Strong engineering and quality background with basic knowledge of statistics/use of Minitab
Strong communication skills
Ability to make independent decisions (proactive, detail-oriented, and solution-driven)
Fluent in English
Light office work and telecommuting capability
Available to travel 20% of the time, as required domestic and international
Must be able to lift and carry up to 50 lbs
Preferred
Previous experience working in a cleanroom environment is highly preferred
Preferred certifications: ASQ Certified Quality Engineer (CQE), Six Sigma Green/Black Belt
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