INTERNAL QUALITY SYSTEM AUDITOR - MEDICAL DEVICES

A world leader in diagnostics healthcare, Roche provides cutting-edge systems for the in-vitro diagnostic, patient self-monitoring, and the research community. Join us in a challenging environment that inspires innovation and creativity.


The Regulatory Compliance Internal Quality System Auditor position is responsible for conducting internal quality system audits for Roche Diagnostic, Indianapolis, IN. This position will manage all aspects of the audit program including audit planning, execution, follow-up and re-audit if necessary. The position's responsibilities include leading internal audits to ensure all areas meet the necessary FDA, ISO, and IVD regulations, while maintaining internal policies and procedures, assist with correction of deficiencies, coordinate CAPA case for completion, and verify effectiveness of actions implemented. This position also participates/lead process/procedure development and improvement initiatives as they related to the Quality System. Cross training and cross-learning of Regulatory Compliance activities is expected. Perform all activities with strong focus on Quality and Regulatory compliance.


Minimum position requirements include a Bachelor's degree in life science or scientific discipline, with at least 10 years experience in a FDA regulated industry. At least 5 years experience in a Medical Device industry. Experience in a Quality Assurance or Regulatory position preferred. Qualified candidates will have knowledge and training on the FDA Quality System Regulation and ISO 13485:2003 Standard. Formal lead auditor training and at least 3 years leading quality systems audits experience is required. Lead Auditor certification preferred. Proven background on statistics, excellent project management skills and experience with processes related to root cause analysis, corrective and preventive action as well as production and process controls. Excellent written and oral communications skills with the ability to produce detailed audit reports and to professionally present thoughts and ideas. Must be capable of interaction with all levels of management. Must be able to work independently with minimal supervision, but also work effectively as part of a team.


Roche Diagnostics is committed to providing equal employment opportunities to a diverse workforce.


Job Level: 5-8 years