Senior Product Complaints Analyst Job in Aliso Viejo, California US
Senior Product Complaints Analyst
Kelly Scientific Resources is seeking an Analyst for Global Products to handle Product Complaints with a leading medical device manufacturer in the South Orange County Area. Monday - Friday, 1st shift 3 month contract w/ possible extension Pay Rate: DOE Primary focus is processing product complaints from receipt to closure, including making reportability assessments, handling follow-up on complaint information, and communicating with other departments. Responsible for receiving and documenting domestic and international complaint files. Ability to perform data entry, file organization create file folders, labels, and filing, use of office equipment fax, scan, copy, etc. and associated duties as required. Ability to make adverse event reporting determinations to meet FDA, and international regulatory requirements Responsible for follow-up of complaint process from initiation to completion with respect to: internal/external communications letters, memos, etc., including follow-up to DHR review, product investigation, and root cause analysis. As required, support senior staff by participating in training, special projects, and/or other complaint related activities Ability to interpret, follow and make required revisions to standard operation procedures Compile, review and close complaint files Qualifications: BS degree in Science strongly preferred, but relation education and experience will be considered Minimum 5 years of related work experience Knowledge of ophthalmic medical terms, Medical Device Reporting regulations, Vigilance reporting regulations, GMPs and ISO Must have strong verbal and written communication skills Proficiency with complaint database management, trending and word processing Interested applicants should apply directly below to the on-line resume builder link. To follow up please contact 714-971-0721.