JOB SUMMARY:
The Quality Engineer processes, investigates, and monitors trending and reporting of medical device product defect complaints, overseeing the documentation and resolution of customer reports and complaints in accordance with the Ultrasound policies and procedures to ensure compliance with global regulatory agency reporting requirements. This includes but is not limited to complaint handling, adverse event reporting, returned product disposition, and analyzing data for monitoring and optimization activities.
This position may also involve interactions with customer service, production, engineering, and clinical research.
RESPONSIBILITIES:
- Ensure all work is performed in compliance with company policy and within the guidelines of the client Ultrasound Quality System.
- Supervise the investigation, resolution, and reporting of all customer-related complaints.
- Coordinate with other departments to obtain necessary information/updates for the resolution of complaints.
- Undertake and complete assignments as determined by Quality Manager or from the department head.
- Generate and submit medical device event reports to appropriate authorities and government agencies as requested and as required by applicable global laws and regulations.
Requirements:
- Experience in Medical Complaint Handling; familiarity with Quality System Regulations (21 CFR 820.196) and ISO 13485.
- Must be able to adapt to change in the workplace and demonstrate flexibility with new ideas.
- Good understanding of operational environment and analytical skills.
- Must be self-motivated and a good team player.
- Exceptional organization skills and attention to detail.
- Ability to perform job function with minimal supervision and work independently taking initiative to make independent decisions, where appropriate.
- Proficiency in using Microsoft Office Applications (MS Word, MS Excel, MS PP, MS Outlook).
- Experience with SAP, Minitab, and SOP writing is a plus.
- 3+ years of professional experience in complaint handling and Quality Assurance, preferably in the medical device industry.
- Bachelor's Degree (required), master's degree (preferred)
- Additional professional certifications are a plus .
