Laboratory Quality Engineer III

Your responsibilities will include: Support laboratory functions to maintain compliance with applicable regulations and standards, validated methods, and internal policies, procedures and work instructions, while promoting continuous inspection readiness. Collaborate with quality management and laboratory management on process improvement initiatives, quality trends and continuous improvement projects. Evaluate the adequacy and compliance of systems, operations and practices through facility- and process-based audits and quality monitoring activities. Support or lead assigned quality projects and initiatives. Contribute to the development and continuous improvement of quality procedures and processes. Assist laboratories in preparation for accrediting body, notified body, FDA or other regulatory inspections. Support the CAPA process in partnership with CAPA owners. Support compliance review meetings in accordance with site procedures. Bachelor's degree in chemistry or related life sciences discipline Strong technical and quality knowledge of ISO/IEC 17025, ISO 13485 and/or 21 CFR 58 Strong verbal and written communication skills, both technical and conversational Minimum of 3 years' experience in a technical role Minimum of 2 years' experience working in a quality role Minimum of 5 years' experience working in the medical device industry or other similarly regulated industry, such as pharmaceuticals, biologics or preclinical environments Strong experience with 21 CFR 58 (GLP)