CQV Packaging

ResponsibilitiesSupport systems engineering activities including design controls, traceability, and design verification & validation (V&V).Maintain documentation traceability from user needs through design validation in compliance with regulatory requirements.Collaborate with cross-functional teams including Quality, R&D, Manufacturing, and Regulatory Affairs.Prepare, review, and maintain technical and quality documentation for regulated products and systems.Support risk management activities and ensure compliance with FDA 21 CFR Part 820, ISO 13485, and related quality standards.Participate in requirements analysis, testing activities, problem-solving, and process improvement initiatives.Qualifications5–8 years of Systems Engineering experience within medical device, pharmaceutical, or other regulated industries.Strong knowledge of design controls, traceability, verification & validation (V&V), and quality systems.Familiarity with FDA regulations, ISO 13485, and risk management principles including ISO 14971.Experience with requirements management tools, traceability systems, and technical documentation practices.Strong analytical, communication, and problem-solving skills with attention to detail.Ability to work effectively in fast-paced cross-functional environments.