SUMMARY

• Complaints Specialist professional with experience in supporting the continued development, improvement, implementation of the Complaints Handling process, Complaint Investigations and Document Control.
• Experienced in root cause investigations, development of corrective and preventive Actions, process verification/ validation, new manufacturing line setup, continuousimprovement, and cost reduction for manufacturing facility of various products to ensure high level of process and productquality.

TECHNICAL SKILLS

• IQ/OQ/PQ
• Troubleshooting
• Investigation
• SOP
• Documentation
• Complaints Handling
• Process Characterization and Validation
• Process Capability analysis
• NCR/CAPA/Root Cause Analysis
• Process Validation
• FDA 21 CFR 820
• ISO 13485
• ISO 14971
• Risk Management/FMEA
• Nonconformance Reports (NCR)
• Nonconformance Material Reports (NCMR)
• Microsoft Applications

PROFESSIONAL EXPERIENCE

Confidential, Illinois

Quality Control Specialist

Responsibilities:

• Reviewing complaints related to medical product ID NOWdevice classification of complaints and escalate complaints that require additional review.
• Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
• Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government - mandated regulations.
• Evaluate and investigate identified complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
• Collect, compile, and document regulatory reportability decisions using event investigation and regulatory decision models.
• Draft Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
• Draft written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers.
• Begins establishing and cultivating a network of internal resources to facilitate completion of tasks.
• Completes daily work to meet established schedule with guidance from supervisor on prioritization of tasks.
• Managing the site Customer Complaint Investigation Program, including responsibility for deciding which complaint will be investigated, coordinating data generating activities.
• Identified events that may be subject to vigilance reporting requirements and communicate with regulatory for evaluation of escalated complaints for potential safety evaluation.
• Complaint handling, analysis, investigation, and documentation of product complaints or reported quality issues and closures in accordance with company guidelines and external regulatory requirements.
• Worked closely withinternal departments for resolution of complaints and escalation to CAPA and Supplier Corrective Action Requests.
• Responsible for deciding which complaints and how they will be investigated, evaluating data and writing investigation summaries/conclusions and closure of complaints.
• Maintaining effective communication with technical service groups (worldwide locations) regarding the site’s product complaint investigations.
• Approve final complaint file for closure after all applicable actions are completed.
• Participated in Product Review Boards. Identify non-conformance trends and develop technical investigation plans. Investigates and analyze customer/internal complaints.
• Coordinated complaint investigations, ensured customers receive the highest level of service and timely resolution to issues.
• Leading and contributing to system, product and process improvement projects maintained and reported to management on Quality and Complaint metrics and trends.

Confidential

Quality Engineer

Responsibilities:

• Responsible for product surveillance data, including customer focus, product risks and performance capability, Device and Combination Products post market surveillance and clinical reviews.
• Performed independent technical assessment on product quality performance and post-market product quality analysis.
• Compiled and analyzed information/data related to nonconformance, deviation, corrective action, root cause, and customer complaint investigations.
• Reviewed all customer complaints, investigations and communications for validity and assures Compliance with policies and procedures.
• Performed and assist in customer complaints and discrepant materials investigations etc.
• Responsible for utilization of database systems used to process complaints, created and measured Quality metrics and electronic MDR reports.
• Collaborated with SMEs from various functional departments to ensure that changes are reviewed and approved, consistent with requirements of site / corporate SOPs.
• Evaluated effectiveness of overall post market processes to resolve gaps or areas for improvement and solutions to mitigate.
• Created and used post-market analytics, statistics and deliverables to report on product quality performance in the field and initiates field actions when required.
• Reviewed audit, investigations, deviations, SOPs, batch records, and corrective and preventive action plans and change controls.
• Performed trend analysis of supplier, internal quality issues, and customer complaints.