Quality Operations Manager

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.

Job Overview

Responsibilities:

• 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.

• 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.
• Significant people management experience.

• 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.