Senior quality engineer (medical devices)


¢ 2 a 2 ,5 millones CRC


Publicado 25 Nov 2021

Aseguramiento de calidad

1 Vacante

Ingeniería Eléctrica - Electrome... / Otras

Empresa confidencial

Sector de la vacante:

Descripción general

Our client requires a Senior Quality Engineer with experience in medical device companies. This position is responsible for providing quality engineering support to operations and product development engineering to investigate, plan, and implementing product quality improvements in and/or additions to current products and manufacturing processes that directly affect safety, quality, regulatory compliance, and/or productivity.

1. Lead and perform root cause analysis in order to determine corrective and preventive action activities.
2. Oversee aspects of quality control and quality assurance including conformance of products and processes to global standards as applicable, assessment and improvement of the quality system, change control approval, and support the internal and/or supplier auditing program.
3. As assigned, maintains various Quality Systems such as CAPA, supplier quality, Non-conformance (NCR), complaints.
4. Evaluate risk, conduct risk assessment activities and create/approve associated documentation.
5. Provide quality engineering input in the design, fabrication, development, installation, validation, and qualification of equipment / processes which may include feasibility studies and/or proper documentation for justification of project and training.
6. Leads preparation and hosting activities for third party audits including FDA, Notified Body, corporate and international regulatory authorities’ audits. Leads follow-up efforts.
7. Plan and implementation of quality related projects to develop, install, and qualify new processes for manufacturing new products or improving existing processes.

Requisitos para aplicar

? Requires a bachelor’s degree in engineering, scientific or technical discipline.
? A minimum of five (5) years of quality assurance related experience in the medical device industry.
? Basic computer software skills, i.e. Microsoft Office.
? ISO 13485 lead auditor training
? Language: English intermediate

Datos complementarios





Equipo medico

5 años de experiencia

Contrato Indefinido


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