Position Overview

Responsible for monitoring and managing all areas of Complaint Handling activities.  Monitors metrics and drives process improvements based on performance trends. Ensure proper analysis of product quality, safety, and reliability issues and effective communication to management and other functions. Initiate and facilitate corrective or preventive actions as needed. Ensure quality customer and regulatory communications for current products.  Assist in ensuring compliance with evolving Global Requirements and Regulations such as MDSAP and EUMDR. The incumbent for this position will support additional activities as assigned.

Essential Job Functions and Responsibilities

Investigate reportable and non-reportable product complaints in accordance with established company procedures and worldwide regulations and standards.  Contribute to continuous improvements to Complaint Handling process. Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Facilitate the progress of complaints throughout the complaint lifecycle to ensure proper documentation and timely closure of each complaint Collaborate with Customer Support, Engineering, and Service teams to support complaint activities Perform reportability determinations in conjunction with medical advisor as necessary. Provides information for timely Adverse Event reporting. Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance Excellent interpersonal skills A self-starter, motivated and able to positively motivate others Focused, target driven with a positive, can-do attitude Support of additional Quality Systems activities, as requested.

Required Qualifications

Bachelor’s Degree in engineering or technical field or equivalent. 5+ year experience working in a regulated industry or similar manufacturing and engineering environments preferred. Advanced English. Strong analytical skills, including the ability to run reports and dashboards; proficiency in Excel is a must. Knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards. Highly organized and detail oriented with strong follow-up skills to manage large volumes of documentation.

Desired Qualifications 

Ability to understand priorities. Ability to work independently and address obstacles that may arise. Ability to work in fast paced and dynamic environment. Strong analytical skills. Excellent written and verbal communication skills. Accuracy is required in performing all functions of this position. Salesforce Experience a plus.