Técnico/a  de Calidad

Requirements:
• Engineer: Industrial Engineer, Biomedical Engineer, Telecommunication or others. • Proven working experience on Quality Area. • 1-2years of overall combined Quality and Regulatory Affairs experience • Experience on FDA Product Submission is a plus. • Experience on CE Mark Audits is a plus. • Experience on Internal and external (Clients) audits. • Microsoft Office advanced skills.• ERP advanced skills. • Ability to obtain, analyze and evaluate data from various databases.• Ability to write Quality procedures and other QUIBIM’s documentation. • Empathic, positive and proactive attitude, problem solving and critical thinking.• Advanced level of English with oral fluency.• Previous experience in digital enterprises and start-ups is a plus.• Curious (never stops learning), team player.• Highly analytical, detail-oriented and a strong sense of business acumen: you have a track record of managing new ideas and creative solutions.• Quality or work- Consistently provides the highest quality product or service. Completes work accurately. Pays attention to detail• Ability to manage and prioritize your workload in a fast-paced, high-growth, occasionally ambiguous environment. • Integrity. • Responsibility, leading the solution to challenges• Proactivity

Responsibilities • Ensure high quality and high performance quality processes. • Implementation of Internal Quality System based on EN ISO 9001 / EN ISO 13485 / FDA 510(k). • CE Mark and FDA requirements’ implementation. • Documentation: record and preparation of technical documentation of the product. • Initiate corrective or preventive actions while funding a non-conformity or process failure. • Quality registration track record. • Reply to customer claims. • Communication of high risk non-conformity to Quality Manager. • Internal audits: coordination and follow-up. • External audits: preparation and coordination of the team. • Manage operational relationship with third parties suppliers, customers, Notified Body and other authorities. • Implementation of Digital Quality System in QUIBIM. • Participation on the identification of products and processes requirements.