Key Skills

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.

Core Responsibilities

Evaluate complaints for eligibility, reportability, and investigation needs; investigate product complaints to confirm events, determine scope, and identify root causes. Report applicable events to authorities and notified bodies, request additional information, communicate outcomes to stakeholders, and manage assigned complaints through closure while upholding quality standards.

Requirements

A bachelor's degree or equivalent work experience is required, along with knowledge of medical device quality management systems and applicable regulations, including 21 CFR 820, 21 CFR 803, ISO 13485, and MDSAP. Candidates need written and spoken English fluency, Microsoft Office and basic SAP skills, and the ability to focus and organize daily work.