Complaint Handling Specialist in Irvine, CA at APEX Systems

Date Posted: 7/11/2019

Job Snapshot

Job Description

Job #:  988007
Medical Device company in Irvine is looking to hire a Complaints Handling Specialist to join their team! 

• 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.

• 2 years of experience

• Effective presentation and interpersonal skills

• Excellent verbal/written communication skills

• Project Management Skills

• Strong attention to detail and accuracy
Please send resumes to
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.