Senior Quality Engineer, P4

Responsible for the communication and documentation of internal and external compliance-related information including changes in regulations, new guidelines and guidance documents and other information from regulatory authorities. Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues. Documents audit non-conformances, evaluates impact, and makes recommendations for corrective actions. Communicates non-conformances to owners, managers, directors, and upper management. Supports departmental, functional, divisional, and corporate quality goals and priorities. Act as leader or team member in supporting quality disciplines, decisions, and practices. Builds quality into all aspects of work by maintaining compliance to all quality requirements. Participates on CAPA and Lean Business project teams as appropriate. Other duties as necessary or required by the department or organisation. Honours Bachelor's degree in Science or Engineering. Minimum 5+ years experience in a medical device manufacturing, quality or regulatory/compliance environment Previous experience in Quality Systems or Country/Distribution QA or having experience in working in the Commercial/Supply Chain organization. Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485 Technical writing and documentation skills Project management skills Degree(s) in Science or Engineering 5+ years of experience in Quality Systems Training/certifications in Quality Management System Requirements (ISO 13485) and FDA Quality System Regulation (21 CFR Part 820) Good working knowledge of SAP would be beneficial Advanced level of Microsoft Excel (including macros) and databases development Software validation experience