Senior Quality Engineer

Pro-actively demonstrate leadership and seniority in the implementation of all Quality standards and procedures in the operational processes, to ensure that processes are executed per Corporate and Regulatory requirements Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues. Pro-actively implements Quality standards and procedures in the operational processes, to ensure that processes are executed per Corporate and Regulatory requirements. Understands and applies quality principles to support an effective overall quality system. Partner with the Global Systems Project Team to support Quality Systems information needs for surveillance of product performance (e.g. SAP improvements, implementation and training). Act as a team member in continuous improvement activities, NCEPs, CAPA and lean initiatives from a quality perspective, for both internal and external customers. Pro-actively investigates, identifies and implements best in class Quality Engineering practices and implements/manages improvement projects within the organization (VIP, QMP, Star, Lean, 5S). Understands and utilizes problem solving methodologies; (CAPA, Is/Is not diagram/Fishbone diagram, Pareto, FMEA). Actively participates in Strategic and site projects. Acts as the Quality Core Team member is a dedicated area or project. Coaches more junior team members in specific Quality systems and processes. Flexibility to perform general QA related activities. Support and prepare for site level internal and external audits and act as Subject Matter Expert (SME) in audits. Collaborates with cross-functional colleagues regarding the impacts of enhancements and process changes. The Sr Quality Engineer may be required to support BSC activities & processes at our 3PL when required. 5+ years' experience with bachelor's degree or equivalent in a manufacturing environment Comprehensive understanding of the MDD/EU MDR, ISO standards and cGMP Demonstrates knowledge in teamwork, SAP, project management, problem solving and risk management techniques Effective team member, fully motivated to achieve and demonstrate best practices in line with the department & global objectives Good social and communication skills Strong analytical skills, eager to improve and results oriented Good knowledge of the English language (verbal and written) Experience with supply chain distribution and packaging Medical device industry experience