Senior Quality Assurance Engineer

Develop, implement, and continuously improve quality policies, procedures, and systems in accordance with ISO 13485, applicable GMP/GDP requirements, and 21 CFR Part 820 . Lead and manage CAPA activities from initiation through effectiveness verification , ensuring timely and sustainable resolution of quality issues. Facilitate structured root cause investigations using appropriate problem-solving methodologies and drive cross-functional corrective and preventive actions. Develop, review, and execute validation strategies and protocols for equipment, processes, software, and test methods , including IQ/OQ/PQ activities. Apply statistical tools and data analysis to identify trends, assess process capability, monitor quality performance, and support data-driven decision-making. Apply risk management, FMEA, SPC, and other quality engineering methodologies to identify and mitigate manufacturing and product risks. Support new product development, design transfer, process development, and manufacturing transfer activities from a quality engineering perspective. Partner with Manufacturing and Engineering to identify opportunities for process optimization, defect reduction, and continuous improvement. Support the development and monitoring of quality metrics and site KPIs; identify trends and recommend appropriate actions. Participate in and support internal, supplier, and third-party regulatory audits , including preparation, response, and follow-up activities. Provide Quality input into nonconformances, deviations, complaints, change controls, and other quality system processes. Support Management Review activities through data analysis, reporting, and presentation of quality performance. Develop and deliver training on quality systems, procedures, problem-solving methodologies, and regulatory requirements. Mentor and provide technical guidance to other members of the Quality organization. Maintain strong documentation practices and ensure quality records are accurate, complete, and compliant. Take on additional quality engineering projects and initiatives as the organization continues to grow. Qualifications: Bachelor's degree in Engineering, Science, or a related technical discipline , or equivalent combination of education and experience. 3–4+ years of Quality Engineering experience , preferably within the medical device or other regulated manufacturing industry . Hands-on experience managing CAPA activities from investigation through implementation and effectiveness checks . Experience developing, reviewing, and/or executing IQ/OQ/PQ protocols . Working knowledge of ISO 13485, 21 CFR Part 820, GMP, and GDP requirements. Experience with root cause analysis and structured problem-solving methodologies . Strong understanding of quality systems, manufacturing processes, and quality engineering principles. Strong analytical, organizational, and problem-solving skills with the ability to manage multiple priorities in a fast-paced environment. Excellent written and verbal communication skills, with the ability to communicate effectively with technical teams, operators, management, and external auditors. Ability to work independently while collaborating effectively across Engineering, Manufacturing, Operations, Regulatory, and Quality functions. Demonstrated ability to influence others and drive projects to completion without relying solely on direct authority. #J-18808-Ljbffr