Quality Control/Complaint Coordinator up to $23hr

Job Description:PLEASE DO NOT APPLY UNLESS YOU HAVE THE SPECIFIC QUALIFICATIONS LISTED BELOW:The Complaint Coordinator is a technical position that is responsible for receiving, documenting and performing complaint evaluations of products according to FDA, European and Canadian requirements for medical device customer complaints. This position interfaces with the Service, Sales, Engineering, Operations, Quality Engineering, Regulatory and Clinical groups, and must interface directly with the customer or their agent in the identification, resolution and initiation of corrective or preventive actions related to customer complaints and complaint product returns.The Complaint Coordinator is a senior technician position that is responsible for all activities associated with the sytem This position will also be cross trained to support the Corrective & Preventive Action System (CAPA). This position will work with the Technical Service Group to review all customer service issues to identify customer complaints, as required by FDA, Canadian, European and international regulations related to medical device manufacturers and will maintain all complaint and complaint investigation files according touality system requirements. In addition to the Service Group, this position will interface and interact with Sales, Engineering, Sustaining Engineering, Operations, Quality Assurance, Compliance and Clinical R&D departments during the research, handling and processing of customer complaints according to corporate systems and procedures, and will report Complaint and CAPA system status to senior management via written reports and communication meetings. The Complaint Coordinator will be responsible for all tasks related to customer complaint identification, root cause analysis, communications and resolution of root cause issues leading to complaint issues, and will responsible for the development and presentation of metrics and complaint trending to senior management during regularly scheduled complaint management meetings. In parallel, this position will also manage the CAPA process, which will be a separately staffed group within the QA and Compliance group. Additional responsibilities include, but are not limited to: Establish and maintain complete complaint files and databases for all customer complaints, according to FDA and international regulatory and compliance requirements related to the complaint system process Review all received complaints to identify if a complaint is reportable under the Medical Device Reporting (MDR) requirements in the USA or the Vigilance System requirements in Europe, and documenting that decision process for all complaints received. This position will train and be qualified for support of the CAPA system process according to procedure Maintenance of all complaint files and records according to established procedures and requirements Derivation and maintenance of all product complaint and CAPA metrics, according to the direction of the Complaint & CAPA Supervisor and VP RA/QA/Compliance & 6-Sigma. Metrics may include top complaint, reliability and service issues related to each product in active distribution, and will moni the effectiveness of other company systems, such as the CAPA and internal audit systems used to support the customer complaint process You can view all of our jobs online at http://www.appleone.com/?sc=11Job Experience:call for details, QA experience/medical device/customer service Searchable Keywords: Customer Service, Inside Sales, Outside Sales, Recruiting, Job Placement / gj-mo Contact Information Company: AppleOne Contact: Anna Clarke E-mail: Apply by Email Address: 92673 Phone: (949) 361-5025 Fax: (949) 361-2606 Reference Code: 11452.1241.ANC-ComplaintCoord.265770* AppleOne is more than just a job. It's a place where you can find the flexibility to pursue your interests while building a career! With more than four decades of experience, our professional career counselors are skilled at matching great people with exceptional career opportunities.