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Cordis · 16 hours ago

Senior Quality Manufacturing Engineer

Irvine, CA

Full-time

Onsite

Mid, Senior Level

$95K/yr - $128K/yr

5+ years exp

Cordis, in partnership with Selution, focuses on developing innovative technology for advanced drug-device combination products aimed at treating coronary and peripheral artery diseases. The Senior Quality Manufacturing Engineer will ensure medical devices meet high-quality standards, manage quality programs, and collaborate with teams to enhance quality management systems and compliance with regulations.

Health CareHealth DiagnosticsMedical

No H1B

U.S. Citizen Only

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

Process Improvement: Continuously identify and implement process improvements to enhance product quality, reduce waste, and optimize manufacturing efficiency

Risk Assessment: Conduct risk assessments related to manufacturing processes and identify potential areas for risk mitigation to ensure the safety and efficacy of medical devices

Regulatory Compliance: 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

Supplier Collaboration: Work closely with suppliers to assess and improve the quality of incoming components and materials, fostering strong supplier relationships

Root Cause Analysis: Investigate and resolve quality issues by performing root cause analysis and implementing corrective and preventive actions

Documentation: Maintain accurate and complete documentation of quality-related processes, inspections, and testing, ensuring compliance with Good Manufacturing Practices (GMP)

Training: Provide training to manufacturing personnel on quality-related procedures, standards, and best practices

Audit Support: Support internal and external audits, including FDA inspections, by providing documentation, data, and expertise related to manufacturing quality

Product Testing: 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

Medical device productionQuality management systemsRegulatory complianceASQ Certified Quality EngineerSix Sigma Green/Black BeltMinitabIndependent decision makingFluent in EnglishCommunication skills