Quality Operations Specialist I - Rose International
Irvine, CA 92602
About the Job
**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.**
Required Skills:
• Bachelor’s Degree
• Years’ Experience: 0-1 years
• Familiarity with Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies pertaining to medical devices
• Familiarity with regulatory reporting requirements for medical devices (e.g. MDRs, Vigilance reports, etc)
• Familiarity with medical device complaint files and quality records
• Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard
• Strong computer skills (including Excel)
• Demonstrated written and verbal communication skills
Role and responsibility:
• Review and investigate assigned technical and clinical customer complaints. Perform technical investigations and document results per established procedures and timelines
• Supports quality functions pertaining to manufacturing line support and maintenance, including SAP
• Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
• Assist complaint intake group through review and verification of initial complaint coding
• Monitor post-market and manufacturing product performance through evaluation and trending of customer complaints, service calls, and manufacturing rejections
• Ensure that appropriate corrective actions are implemented to address the root cause of trending issues
• Support and coordinate product/process improvements through collaboration with cross-functional teams (Quality, Manufacturing, R&D, Supply Chain, Finance, etc)
• Ensure compliance with the Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies pertaining to medical devices
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.).