Quality Assurance Complaints and Compliance Specialist

Main Duties and Responsibilities

ISO 13485 Responsibilities

• Serves as the lead to ensure accurate and timely compliance reporting in accordance with ISO 13485 and FDA Quality System Regulations.
• Reviews and evaluates technical services enquiries and complaints for validity and accuracy.
• Manages and updates TSS Tickets.
• Collaborates with TSS team members.
• Reviews and maintains compliance files and ensures review and approvals have been obtained within timeframes outlined.
• Records, documents, and posts meeting minutes for compliance team meetings.
• Compiles, Prepares, Reviews, and Manages compliance reports (Complaint, eMDR, NCR, CAPA, SCAPA, & Recall) in close collaboration with Technical Support Services and Quality Assurance & Regulatory Affairs management.
• Supports validation activities associated with Compliance reporting in accordance with current regulatory requirements.
• Serves as lead Core Team Member to establish training program for Compliance Reporting.
• Ensures that compliance reports are entered into the quality record in close collaboration with all stakeholder departments.

FDA/Regulatory Responsibilities

• Submits MDRs and Recall advisories according to FDA requirements and ensure that all follow-up activities are completed and are communicated to manufacturer as required.
• Completes required compliance reports as required by applicable federal, state and local regulatory agencies.
• Participates in external and internal regulatory audits as required for matters related to TSS & Compliance Reporting.

Training: Design and Establish training and training programs for complaint handling and compliance.

Trending: Establish and maintain departmental Metrics and Trending.

Qualifications

• Educational Background: Bachelor Degree in a biological science-related field. Biomedical Engineering Masters Degree preferred.
• Requires in depth understanding of FDA 21 CFR Complaints: 820.198 & ISO 13485: Improvement (Sec. 8.5.1) MDR (FDA 21 CFR 803.17 & 803.50(a)(1)) is required with a minimum of 3 years experience in complaints handling and compliance reporting in the field of IVDD, clinical diagnostics, and medical device industry.
• Strong investigational and problem solving skills. Root cause analysis techniques a plus.
• The ability to communicate Quality System requirements and manage compliance of same is expected.
• Must work across functional teams within the organization
• Attention to detail and timeliness are critical and a must
• Excellent communication (verbal and written) and interpersonal skills required
• Basic statistical methods including trend analysis, pareto, and other basic charting techniques is a plus.