Quality Engineer

2 weeks ago

Irvine, United States Rose International Full time

Description:

The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices. Responsibilities include collaborating with internal and external stakeholders to achieve company objectives, leading technical root cause investigations, developing and executing risk-based decisions, resolving and documenting customer complaints and manufacturing investigations, and representing Quality in cross-functional projects.

Job Duties:

Develop and execute plans for quality and control to ensure manufacturing continuity and product conformance.

Leads investigations into production and customer-facing quality issues to identify root causes, implement corrective and preventative actions, and monitor effectiveness

Monitors and analyses product performance of medical devices using a statistical and risk-based approach. Considers any quality, compliance, customer, and business risks.

Performs hands-on troubleshooting of customer-returned devices and manufacturing nonconformities and completes associated technical documentation

Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization

Proficient in project management, data analysis, root cause analysis, communication, and risk determination

Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies about medical devices.

Must-Have Requirements:

Bachelor’s degree in engineering

College Grads (encouraged to apply)

  • **Only those lawfully authorized to work in the designated country associated with the position will be considered.**

  • **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**

Benefits:

For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.

California Pay Equity:

For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.

Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).

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