What are the responsibilities and job description for the Quality Engineer position at Collabera ?
Key Responsibilities :
Design Control & Regulatory Compliance :
Guide and influence cross-functional teams through design modifications, validation, and regulatory compliance activities. Ensure robust product design and alignment with customer requirements. Assess the impact of manufacturing process changes on product quality and performance. Provide well-documented justifications for changes, including impact assessments on critical parameters and other affected systems / products. Demonstrate a strong understanding of the design control lifecycle, including design inputs, verification, validation, and commercialization. Apply knowledge of In Vitro Diagnostic Regulation (IVDR) standards to the design and development process (preferred). Quality Systems & Compliance :
Maintain and ensure compliance with the Quality Management System (QMS) for medical devices designed or manufactured by the unit. Ensure adherence to internal policies and procedures, as well as regulatory requirements (e.g., FDA, ISO 13485, IVDR). Support internal and external audits by providing documentation and demonstrating compliance with quality standards. Cross-functional Collaboration & Communication :
Act as a QA representative on project teams, collaborating with R&D, Manufacturing, Regulatory, and other stakeholders. Communicate confidently and effectively with management, cross-functional teams, and key stakeholders. Provide guidance on quality assurance best practices to drive continuous improvement and ensure high product quality. Qualifications & Experience :
Education : Bachelor’s degree in Life Science, Engineering, or a closely related discipline. Experience : Minimum 5 years of experience in Quality Assurance or related fields (e.g., diagnostic quality, technical areas). Experience in the healthcare or medical device industry is preferred. Prior experience with assay development or assay support is a plus. Familiarity with IVDR standards and their application in design and manufacturing processes is advantageous. Strong understanding of design controls, validation, and regulatory requirements for medical devices. Excellent problem-solving, analytical, and communication skills. Preferred Skills :
Experience with assay development and support. Knowledge of FDA, ISO 13485, IVDR, and other relevant regulations. Ability to manage multiple projects and prioritize tasks in a dynamic environment.
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