Quality Complaints Coordinator

Product Complaints Coordinator
Northridge, CA (100% on-site)
Pay: $30-35

ROLE SUMMARY

Our client, a leading CDMO located in Northridge, CA, is seeking a highly organized and detail-oriented individual to join our quality assurance team as a Quality Complaints Coordinator. The Quality Complaints Coordinator will play a critical role in managing and investigating customer complaints related to our products or services. This position requires a strong understanding of quality management systems, excellent communication skills, and the ability to work collaboratively across departments to ensure timely resolution of complaints and implementation of corrective actions.

ROLE RESPONSIBILITIES

• Receive, document, and investigate customer complaints regarding product quality, performance, or safety. Ensure complaints are logged into the appropriate tracking system and assigned for investigation.
• Conduct thorough investigations into each complaint, gathering relevant information from internal sources (e.g., production/batch records, quality control data) and external sources (e.g., customer feedback, returned products). Analyze data to identify root causes of complaints and contributing factors.
• Collaborate with cross-functional teams, including manufacturing, quality control, and regulatory affairs, to investigate complaints and implement corrective and preventive actions (CAPAs) as needed.
• Ensure that all complaint handling activities comply with relevant regulatory requirements, industry standards, and Kindeva policies. Maintain awareness of changes in regulations and standards related to complaint handling and quality management.
• Communicate with customers regarding the status of complaint investigations, resolution actions, and any follow-up required. Provide timely and accurate responses to customer inquiries and ensure customer satisfaction.

Maintain accurate records of complaint investigations, including documentation of findings, corrective actions taken, and closure of complaints. Generate reports on complaint trends, root cause analysis, and effectiveness of corrective actions.

BASIC QUALIFICATIONS

• Bachelor's degree in a related field or equivalent work experience.
• Previous experience in quality assurance, complaint handling, or a related field, preferably in a regulated industry such as pharmaceuticals, medical devices, or consumer goods.
• Familiarity with regulatory requirements such as FDA regulations, ISO 13485, or other relevant quality standards.
• Excellent analytical skills and attention to detail, with the ability to conduct thorough investigations and analysis.
• Effective communication and interpersonal skills, with the ability to interact professionally with customers and internal stakeholders.
• Proficiency in Microsoft Office applications and experience with complaint tracking software or customer relationship management (CRM) systems.