Quality Manager
hace 3 semanas
Descripción y detalle de las actividades
RESPONSIBILITIES 1. QA Manager is responsible for strategic oversight and leadership direction to ensure and maintain the effectiveness of the quality system, as well as compliance with the regulatory requirements 21CFR part 820, ISO13485:2016, ISO9001:2015 & MDR 2017/745. 2. Demonstrates understanding of quality philosophies, principles, systems, methods, tools, and standards to develops and implements quality programs and process improvement initiatives to ensure compliance of final product quality standards and delivery for the achievement of quality objectives. 3. Acquires and analyzes data using appropriate standard quantitative, statistical methods to facilitate process analysis and Provide support in engineering projects focused on continuous improvement. 4. Applies problem solving and quality improvement tools and techniques, including, preventative and corrective actions to overcome barriers to quality improvements and management of the system to the properly documented and carried out in a timely manner, as well as monitor their effectiveness. 5. Understands product design, design transfers, and production line quality standards, i.e., controls, process quality in accordance with quality principles, which include planning processes, design control, material control, acceptance sampling and measurement systems. 6. Demonstrates knowledge of reliability, maintainability, and product risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting. 7. Experience with performing process validations (IQ/OQ/PQ), equipment qualification, and test method validations. 8. Strong communication skills (written and verbal); ability to present communication plans and status updates to customers 9. Supervise the internal audit program, ensuring its compliance with the applicable standards. Direct support in any client or notifying body audit. 10. Lead in training and implementation of all related to the regulatory quality system, Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDPs).
Experiência y requisitos
REQUIREMENTS - Bachelor’s degree in Engineering, related field, or equivalent work experience in focused area. - 3+ years as QA Manager, QA Coordinator in related field within medical device manufacturing. - Advance English (read, write, speak) - Solid leadership and mentorship experience COMPETENCES AND SKILLS: - Proven experience within a medical device manufacturing environment, governmental regulations, and standards (21 CFR Part 820, ISO13485, MDR). - Demonstrated knowledge and experience of medical device risk management standards (ISO14971). - Demonstrated knowledge and experience with FDA QSR for medical product Design Control process and design/product transfers. - Strong in the use of statistics theory and analysis - Preferred experience in Project management, 6 Sigma process improvement methodologies, Kaizen, Lean manufacturing, and green/Black Belt certification is a plus.
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Horario** 7AM-5PM, LUN-VIE
**Estudios** Titulo Profesional
**Inglés **Hablado: 85%, Escrito: 85%
**Sexo** Indistinto
**Disponibilidad p. viajar** No
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