Complaint Vigilance & Quality Investigation Specialist

Envista Holdings Corporation; Venlo; On-site; EUR 55,000 - 70,000; Full time

Job summary

Envista (Nobel Biocare Envista) seeks a Complaint Handling & Vigilance Specialist to evaluate complaints for eligibility and reportability, conduct investigations, and ensure compliant reporting to authorities. The role requires English proficiency, familiarity with quality systems, and collaboration with QA and Postmarket Surveillance.

The position emphasizes investigating root causes, coordinating with Customer Service, and maintaining documentation quality across the process.

Qualifications

• Bachelor’s degree or equivalent work experience.
• Knowledge of medical device quality management systems 21CFR820 and 21CFR803, ISO13485, MDSAP and other applicable regulations and guidelines.
• Fluency in English, both spoken and written.

Responsibilities

• Evaluate complaints on eligibility, reportability and need for investigation.
• Report events to applicable authorities and notified body.
• Requests more information when needed from Customer Service.
• Perform investigations to confirm the complaint, determine the scope and find the root cause.
• Communicates outcomes to stakeholders, like customer service (customer report), Quality Assurance and Postmarket Surveillance.
• Manage their assigned tasks and workload.
• Acts as a resource for colleagues with less experience.
• May lead small projects with manageable risks and resource requirements.
• Upholds quality standards, like Good Documentation Practises, Line Clearance, Reconciliation

Skills

English fluency

Organizational skills

Education

Bachelor's degree or equivalent

Tools

SAP

Job description

Envista (Nobel Biocare Envista) seeks a Complaint Handling & Vigilance Specialist to evaluate complaints for eligibility and reportability, conduct investigations, and ensure compliant reporting to authorities. The role requires English proficiency, familiarity with quality systems, and collaboration with QA and Postmarket Surveillance.

The position emphasizes investigating root causes, coordinating with Customer Service, and maintaining documentation quality across the process.