Technical Complaint Specialist
- ישראל
- משרה קבועה
- משרה מלאה
- Complaint Management: Receive, assess, and document field feedback to identify potential complaints related to medical devices. Meticulously manage complaints through their entire lifecycle, from initial intake to closure, adhering to established processes and timelines.
- Regulatory Reporting: Prepare and submit Medical Device Reports (MDRs) to regulatory agencies (e.g., FDA, EU Competent Authorities) in accordance with applicable regulations and internal procedures.
- Data Analysis & Trending: Maintain and analyze the complaint database to identify trends and potential safety issues. Prepare reports and presentations for management review.
- Process Facilitation: Trigger and facilitate related processes based on complaint trends and individual investigations, including:
- Failure Investigations
- Corrective and Preventive Actions (CAPA)
- Post-Market Risk Assessments (Hazard Analysis)
- Customer Communication (as needed)
- Correction and Removal Review Board Meetings
- Audit & Inspection Readiness: Compile and maintain comprehensive documentation related to complaints and reporting, ensuring the organization is prepared for internal and external audits and inspections.
- Bachelor's degree or equivalent, required. A degree in a scientific, engineering, or technical field, preferred. Biomedical Engineering is a significant advantage.
- Minimum of 3 years of direct experience in complaint handling within the medical device industry.
- Minimum of 2 years of industry experience in an engineering role, preferably Biomedical Engineering.
- In-depth understanding of medical device regulations and standards, including:
- ISO 13485 (Quality Management Systems)
- ISO 14971 (Application of Risk Management to Medical Devices)
- 21 CFR Part 820 (FDA Quality System Regulation)
- EU MDR (EU Medical Device Regulation)
- A strong emphasis on: Complaints, Risk Management, Recalls/Removals, CAPA, and Medical Device Reporting requirements.
- Excellent written and verbal communication skills in English.
- Proven ability to coordinate complex activities, prioritize tasks, and resolve problems effectively using both technical expertise and strong interpersonal skills.
- Strong team player with excellent interpersonal and negotiation skills to effectively manage competing priorities.
- Experience with quality tools, database systems, and data analysis techniques.
- Certification from a professional quality organization (e.g., CQE) is a plus.