The posting
IMDS - Interventional Medical Device Solutions Quality Assurance Engineer Fulltime (36-40 hours) About the Job: We offer a challenging position for a Quality Assurance Engineer professional in an innovation driven Medical Device Company. You are part of the IMDS QA/RA team where you take ownership for driving compliance with our operations - and development process and the quality of our products. You enjoy working in a multi-disciplinary environment, you are highly skilled in communication, and you have a can-do attitude. You realize that quality is of paramount importance and you are passionate about delivering solutions that truly stand out. Tasks & Responsibilities: The Quality Assurance Engineer participates both within an Operations environment as well as a New Product Development environment. Typical tasks for the Quality Assurance Engineer are: - Review of Engineering -, Qualification- and Validation protocols and reports - Review of New Product Development documentation - Review of Specifications, Calibration- and Maintenance records - Maintenance of Quality Management Procedures, - Guidance's and - Templates - Prepare and organize the Quality Management System Review meetings - Coordinate handling of Non-Conformance Records, CAPA's and complaint investigations - Coordinate Cleanroom Monitoring and Corrective Actions - Coordinate Bioburden Monitoring, Endotoxin Monitoring and Periodic Dose Audits - Train new employees on Quality Management System - Prepare and execute internal audits (ISO 13485, cGMP) and DHF audits Job Requirements: - BSc or MSc degree in exact sciences (e.g. Business Engineering) - Strong feeling for an engineering environment - Minimal 2 years of medical device work experience in QA - Highly committed, respectful, trustful, eager and demonstrate ownership - Creates alignment between cross functional team members through effective communication and seeks cross-function cooperation - Has sufficient tec...



