Senior Quality Systems Engineer

Experienced Senior Quality Systems EngineerWe are seeking an Experienced Senior Quality Systems Engineer to join our client's team as a key member of the Quality Systems department.Work schedule: (M-F) 8am - 5pmPay rate range: $200,000 -$235,000/yearJob RequirementsBachelor's degree (or equivalent) in Engineering, Science, Quality or a related discipline.A minimum of 5 years of related experience with a Bachelor's degree; or 3 years and a Master's degree; or a PhD without experience.Additional qualification in Quality Assurance or a related discipline is preferred.ISO 13485 Auditor training and/or Lead Auditor qualification is preferred.General ResponsibilitiesPrioritise and manage workload to ensure critical Quality System activities are delivered on timeEscalate compliance risks and resource constraints appropriatelySupport broader Quality or site activities where required, provided core Quality Systems responsibilities are not impactedEssential Skills and ExperienceStrong working knowledge of ISO13485 and applicable regulatory requirements.Experience in CAPA, internal auditing, customer complaints and audit support, including leading audits and supporting external inspections.Proven ability to lead investigations and drive timely resolution of quality issues, including root cause analysis and follow-up actions.Experience working with electronic Quality Management Systems (eQMS), including data management, tracking and reporting of Quality Systems activities.Experience working cross-functionally and influencing stakeholders across Quality and Operations.Strong problem-solving, organizational and communication skills, with the ability to work independently, manage priorities and escalate risks appropriately.