This job is posted on behalf of Step Up Recruiting by Top Echelon.

ROLE SUMMARY

We are 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

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• 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.
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• 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.
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• Collaborate with cross-functional teams, including manufacturing, quality control, and regulatory affairs, to investigate complaints and implement corrective and preventive actions (CAPAs) as needed.
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• Ensure that all complaint handling activities comply with relevant regulatory requirements and industry standards. Maintain awareness of changes in regulations and standards related to complaint handling and quality management.
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• 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.
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• 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.
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BASIC QUALIFICATIONS

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