Irvine, California, United States
Job type: fulltime
Job industry: I.T. & Communications
Position : Complaint Specialist
Location: Irvine, CA
Independently lead others and conduct internal quality system and regulatory assessments with minimal guidance or supervision. Work closely with and coach employees in the development of effective corrective action plans to address internal audits and CAPAs. Ensure quality and adherence to Quality System and GMP requirements. Publish audit reports and maintain CAPA, Audit and Complaint database records. Oversee the complaint management system to ensure data is thoroughly analyzed and decisions are properly documented to comply with the regulations.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
Manage Complaint Handling System and coordinates with other subject matter experts to ensure data is properly analyzed and reporting decisions are document adequately.
Generates metric reports as needed. Provide Status reports to management as required.
Ensure continued compliance with FDA s QSR, ISO 13485 and other regulatory requirements.
Assist with the administration of the CAPA system (CAPA Specialist). This includes and is not limited to monitoring timely closure of action items, gathering metrics, collaborating with owners to ensure CAPAs are effectively managed and auditing the files for objective evidence of corrective actions.
Participate in process improvement projects and Regulatory Affairs requests.
Support process owners to address internal/external audit findings.
Collaborate with functional owners across the organization to ensure training needs are clearly identified and gaps closed.
Review of inquiries to ensure proper classification.
Review of Complaints: MDR Reporting and Evaluation, creation and timely finding of DMRs, Failure investigation and Complaint Closure.
EDUCATION/CERTIFICATION: BA required
Excellent computer skills: Proficient in Microsoft Office, Quality Systems Software
Understanding of FDA 21 CFR 820 and ISO 13485 Requirements
Understanding of Problem Solving Methodologies
Complaint Handling Requirements, Post Market Surveillance, Medical Device Reporting: 21 CFR 803, Reports of Corrections and Removals: 21 CFR 806
5 years of experience
Effective presentation and interpersonal skills
Excellent verbal/written communication skills
Project Management Skills
Strong attention to detail and accuracy