Quality Engineer - IVDR Transition

Need suitable Quality Engineer profiles with experience in IVDR and EU MDR. Medical Devices exp required Job Title Quality Engineer IVDR Transition This position has the responsibility of working in the Quality Engineering IVDR Work stream to plan and execute engineering activities with a focus on design verification and validation, translation of product specifications into the controlled manufacturing environment, and compliance with relevant harmonized standards. The successful candidate will support the remediation of QMS documentation relative to the European In-Vitro Diagnostic Device Regulations (IVDR), ensuring QMS compliance with applicable requirements. Technical/Functional Skills Ability to define requirements, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions. Good problem-solving skills through the use of quality and statistical tools Competent (with a proven record of accomplishment) in writing and executing successful validation plans. Knowledge of post-implementation continuous improvement efforts and methodology. Proficiency with using Microsoft Office Suite and Minitab Experience with small material measurement equipment (examples include: Vertex Automated Precision Measurement Systems, Instron, Toolmaker Microscope, Calibrated Calipers) Experience with chemical reagent manufacturing and inspection processes Experience with ISO 13485, EU IVDD / IVDR certified quality systems Practical experience with CAPA and supplier quality Experience Required Minimum of 6 years of progressive experience in development and/or manufacturing of medical devices; in vitro diagnostic assay manufacturing experience strongly preferred Basic understanding of immunoassays Roles & Responsibilities Work with project and functional managers to determine action items and deliverables and address gaps in current documentation. Revise and create controlled documents, including documentation of the transfer of product specifications into controlled manufacturing process SOPs Plan and successfully execute the control plan activities to address mitigation plan leading to product compliance with IVDR Provide relevant information to IVDR cross-functional team ranging from Device History Records, Control Charts, and SOPs Carry out all aspects of a validation including: Authoring/reviewing/executing process validations, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols/report, risk assessments, and periodic reviews in accordance with corporate and departmental procedures Analyze control chart information, draw the right conclusions based upon technical knowledge of the systems, and work effectively with different groups across site to ensure correct interpretation of the information Establish and improve process methods which meet performance and quality requirements Perform process-capability studies to assess the ability of the existing manufacturing processes to meet specifications Generic Managerial Skills Not Mandatory Education Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred Start date (dd-mmm-yy) 6-JUN-21 Duration of assignment (in Months) 12 months Work Location (State, City and Zip) Claymont, Delaware 19703 Regards Rahul Singh Account Manager Email: Phone UNITED SOFTWARE GROUP Inc. eye