Quality Manager

Job Responsibilities Responsible for full spectrum of Quality function in a medical part manufacturing operations with QC laboratory support. Lead a team of Engineers, Technicians, and Inspectors within the quality department. Maintain and ensure operations’ QMS in compliance with ISO 13485 and ISO 9001 and other regulatory standards. Involved with Quality Operations in the area of quality control and assurance leading to product output and specifications meeting customer standards and requirements. Maintain stringent quality lab testing protocols and safety standards. Manage and plan capital equipment expenditure and control annual budget for sustaining and expansion purposes. Involved in NPI and quality engineering work with internal stakeholders on new/existing product development to ensure compliance and production readiness. Collaborate with the Global Quality team to align and drive global initiatives. Lead and prepare for all internal and external audits from customers to regulatory bodies. Supplier quality management through audits, reviews, and partnership management. Continuously seek quality improvement initiatives through project formation to increase manufacturing efficiency and reduce product quality issues. Work closely with manufacturing, engineering, R&D, and procurement on operations non-conformance, identifying root causes and following up with sustainable corrective actions. Requirements Degree/Masters in Engineering. Minimum 10 years of working experience in quality engineering management in an MNC manufacturing environment with proven people leadership. Knowledge of ISO 13485 and ISO 9001 and understanding of validation and verification processes for medical parts manufacturing. Display strong knowledge and application of problem-solving tools: SPC, Six Sigma, Lean principles. Experience handling multiple projects with internal and external stakeholders. Individual to be analytical, attentive to detail, possess high integrity, and be proactive. #J-18808-Ljbffr