Complaint Handling Specialist in Irvine, CA at Apex Life Sciences

Date Posted: 11/9/2018

Job Snapshot

  • Employee Type:
  • Location:
    Irvine, CA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

Medical Device company in Irvine is looking to hire a Complaints Handling Specialist to join their team! This position will pay $30-40/hr and will turn into a permanent opportunity. 

• 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.



• 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

Please send resumes to

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, 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.