Quality Assurance / Complaints specialist

Diagnocat is the global technological leader in AI solutions for Dentistry. Our imaging solutions allow dentists to make fewer diagnostic errors and save time by incorporating computer vision into their workflow.

Diagnocat holds multiple patents, CE mark, and registration on the majority of EU countries. We work in multiple countries and have hundreds of clinics worldwide as our paying customers.

We are seeking a dynamic and experienced Complaints specialist to join our team.

What we offer:

• Your work will have a direct positive impact on the lives of the patients with a breakthrough innovative product.
• Fully remote work options.
• Working in a fast-growing company, in a startup atmosphere.
• Fixed competitive monthly payment.

Key Responsibilities:

• Complaint Handling:
  • Receive, review, and document customer complaints related to medical devices.
  • Classify complaints according to severity and risk, and escalate critical issues as necessary.
  • Maintain accurate records of complaint investigations, including findings, actions, and resolutions, in accordance with internal procedures and regulatory standards.
• Complaint Investigation:
  • Conduct detailed investigations of complaints, including root cause analysis, working closely with cross-functional teams.
  • Gather and analyze data from production records, product specifications, and quality control reports to identify potential causes of product defects or failures.
• Corrective and Preventive Actions (CAPA):
  • Initiate and manage CAPA plans based on investigation findings.
  • Monitor the implementation of corrective actions and verify their effectiveness in preventing recurrence of issues.
  • Track and report on CAPA progress.
• Regulatory Compliance:
  • Ensure complaint investigations are conducted in compliance with applicable regulatory requirements (e.g., FDA, ISO 13485, MDR, etc.).
  • Assist in regulatory audits and inspections by providing documentation and explanations related to complaint handling and investigations.
  • Stay updated on current regulatory guidelines and standards affecting complaint management.
• Data Analysis and Reporting:
  • Analyze complaint trends and prepare periodic reports.
  • Identify opportunities for process improvements based on complaint data and investigation outcomes.
  • Support quality improvement initiatives and provide feedback.

Required Skills and Experience:

• Experience:
  • At least 2 years of experience in quality assurance, complaint handling, or investigations within the medical device or healthcare industry.
  • Strong knowledge of ISO 13485 related to complaint handling and CAPA. Knowledge of additional regulatory requirements such as FDA 21 CFR Part 820, MDR, etc., will be considered an advantage.
• Skills:
  • Excellent analytical and problem-solving skills with a strong attention to detail.
  • Proficient in root cause analysis techniques and tools (e.g., Fishbone Diagrams, 5 Whys, Fault Tree Analysis).
  • Strong communication skills, both written and verbal.
  • Ability to manage multiple investigations simultaneously and prioritize tasks effectively.
  • Proficiency in using quality management systems (QMS) and complaint tracking software.