Job Overview Oversee and drive continuous improvement of product Quality and Compliance within TE Medical.Establish and maintain a culture of continuous improvement for enhanced compliance, effectiveness, and efficiency.Ensure full procedural compliance with regulatory requirements (21 CFR 820, ISO13485, RDC ANVISA 16/2013, MHLW MO 169, TG(MD)R sch3, and others).Focus on Health and Safety initiatives aligned with plant objectives, including accident reduction and implementing 5S+1 program successfully.Lead TEOA (TE Operating Advantage) program implementation for performance improvement.Collaborate with business units and Engineering Manager to achieve cascaded Plant objectives.Develop a Quality Operations Strategy for the business unit and foster a culture of Quality improvement and innovation.Champion Cost of Poor-Quality initiatives and develop strong customer relationships.Ensure comprehensive compliance with the Quality Management system across all activities.Participate in new product introductions, embedding quality from early product lifecycle stages.Implement and maintain effective process controls (inspection standards, plans, frequencies, test methods).Manage and develop Quality staff, promoting awareness of regulatory requirements and Quality Management system.Develop and implement Manufacturing procedures and systems ensuring product compliance with specifications.Monitor and report department metrics, objectives, and personnel development/training.Support regulatory agency and customer Quality audits and manage Corrective and Preventive Actions.Authority to place products or processes on hold, design quality recording forms, and drive problem-solving techniques for process-related issues.Lead cross-functional teams as needed to resolve product or process-related issues or objectives.What your background should look like: Level 8 degree in Science, Engineering, or related subject.7+ years of relevant Quality Operations experience in a GMP Manufacturing environment within the Medical Device/Pharma industry.Key Requirements: Experience facing regulatory audits.In-depth knowledge and commitment to ensuring compliance with FDA, Quality System Regulations, ISO standards, and other regulatory requirements.Proactive team player with excellent communication, leadership, organization, and investigation skills.Strong problem-solving and innovation abilities.
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