We are seeking a detail-oriented and technically proficient Complaint Specialist to manage the entire complaint lifecycle for medical devices. In this critical role, you will be responsible for ensuring compliance with our Quality Management System (QMS) and all applicable regulatory requirements, including the timely and accurate reporting of adverse events to relevant authorities. You will also play a key role in identifying trends, facilitating investigations, and driving continuous improvement in product safety and performance.

Responsibilities

• 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.
  

Qualifications

• 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.
  

Reports To: Head of QA & RA