Senior Quality Engineer-Electrophysiology
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• Develop, coordinate and control actions to monitor and analyze quality performance according to customer’s specifications and quality standards.
• Investigate product or process high level/impact issues, to determine root cause and implement the corresponding action to avoid recurrence and improve processes.
• Lead quality planning throughout the New Product Introduction (NPI) process by translating customer, design, and regulatory requirements into measurable quality requirements.
• Lead quality/regulatory initiatives to promote compliance in the operations/engineering areas.
• Lead action that promotes the implementation of cost savings in the Quality Sustaining Area and be aligned with company expectations.
• Develop and mentor quality engineering talent by providing coaching, technical guidance and opportunities for professional growth. Promote a culture of quality, accountability, collaboration, and continuous improvement. KNOWLEDGE, SKILLS AND ABILITIES
• Bachelor’s degree in engineering discipline or Business Sciences.
• 5+ years of experience in related positions including Quality Assurance, Change Control, QMS.
• 4+ years leading work teams of specialized people.
• 3+ years managing Quality controls (SOPs, Work Instructions, specifications, guidelines).
• Fluent in spoken and written business English and Spanish
• Specialized knowledge in Quality Assurance and related areas.
• Proficient in using Quality Management Systems and ERP solutions.
• Negotiation skills to drive different criteria from multidisciplinary teams.
• Understanding of CAPA, statistical analysis, SPC, and Lean tools.
• Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership techniques, inspections methods, and coordination of people and resources.
• Proficient with Microsoft Office.
• ASQ certified Quality engineer is a plus.
• ISO 13485:20XX auditor is a plus.
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