Complaint Handling & Vigilance Specialist

envista; Venlo; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Envista's Complaint Handling & Vigilance Specialist evaluates each complaint for eligibility and reportability, conducts investigations following regulatory guidelines, and handles reporting and closure of complaints with supervisory support.

The role collaborates with Customer Service, Quality Assurance, and Postmarket Surveillance, manages workload, and may lead small projects while upholding industry standards and documentation practices.

Qualifications

• Bachelor's degree or equivalent work experience.
• Knowledge of medical device quality management systems 21CFR820, 21CFR803, ISO13485, MDSAP and other applicable regulations.

Responsabilités

• Evaluate complaints on eligibility, reportability and need for investigation.
• Report events to applicable competent 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, 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.

Connaissances

Fluency in English

Microsoft Office

Time management

Formation

Bachelor's degree or equivalent work experience

Outils

SAP

Description du poste

Job Description:

The Complaint Handling team's purpose is to create relevant data that leads to improvement to satisfy the customer's needs. For this the Complaint Handling & Vigilance Specialist will evaluate each complaint on eligibility and reportability according to standard operating procedures based on applicable regulations and guidelines.

Investigations of product complaints are conducted following analytical/scientific methodology.

The Complaint Handling & Vigilance Specialist is responsible for investigation, reporting and closing the assigned complaints and works with a moderate degree of supervision.

The Complaint Handling & Vigilance Specialist is accountible for:

• Evaluate complaints on eligibility, reportability and need for investigation


• Report events to applicable competent authorities and notified body


• Requests more information when needed from Customer ServicePerform 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

Job Requirements:

Critical Knowledge and 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.

Critical Skills/technical know-how:

• Fluency in English, both spoken and written.


• Microsoft Office/basic ERP (SAP) skills.


• Be able to focus on the task and organize their day to day work.

Operating Company:

Nobel Biocare Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.