Quality assurance engineer staff

801562

CRC Salario confidencial

Costa Rica Toda Costa Rica

Publicado 26 Mar 2021

Aseguramiento de calidad

2 Vacantes

Ingeniería Eléctrica - Electrome... / Otras

CONFLUENT MEDICAL TECHNOLOGIES
Industria de la empresa:
Industrias manufactureras

Descripción general

*MEDICAL INDUSTRY EXPERIENCE IS A MUST.* Bachelor degree in a related engineering discipline 4-6 years of related experience combining a variety of manufacturing process, technologies and Quality Systems areas (i.e. but not limited to: Process Validation, Software Validation, Risk Management, Suppliers management, CAPA, Complaints, NCRs, Calibrations, Audits, Document Control, Quality Control, Quality Metrics and Change Control). Works on problem solving and improvement projects of moderate scope where analysis of situation or data requires a review of identifiable factors. Participates in decisions on scope of work, selection of equipment and length of tasks. Participates on design changes analysis to meet revised specifications during manufacturing. Provides and develops solutions to problems of limited scope. Must be able to accomplish broad assignments. Provides technical guidance to piers in the work team. Writes and runs manufacturing validation protocols, test method validations and software validation among others. Work on interdisciplinary teams. Works on interdisciplinary teams for manufacturing improvement or process transfer projects at site level as required.

Requisitos para aplicar

Applies and maintains quality for processing materials/products into partially or finished products. Implements methods for inspecting, testing and evaluating products and production equipment. Analyzes reports and recommends corrective action. Responds to Supplier Correction Action Responses. Prepares documentation for inspection/testing procedures. Plans and conducts work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria. Devises approaches to problems. Responds to common inquiries from customers, regulatory agencies, or members of the business. Independently performs most assignments with instructions as to the general results expected. Receives technical guidance on moderate complexity problems and supervisory approval on proposed plans for projects. Plans, schedules, conducts, and coordinates detailed phases of engineering work.Performs work which involves conventional engineering practices. Acts as validation assessor for manufacturing processes.Participates in validation efforts for process at sustaining stage or sound start-up of new processes.Develops validation protocols and reports for process and test method validation efforts and strategies.Approves validation documentation.Drives documentation and process changes.Technically supervises the work of technicians.Provides guidance on acceptance criteria of the manufacturing lines. Conducts internal audits and provides support to external audits. Responds to complaints from customers investigating the root cause. Supports migration/integration of Quality Systems between transfer. Supports validation strategy for transfers. Participates in proactive team efforts to achieve departmental and company goals. Ensures non-conforming product is segregated and disposed as per internal procedures. Supports Risk Management plans (pfmea) development. Supports CAPA for process and Quality System improvement.

Datos complementarios

801562

Coordinador supervisor o especialista

Ingeniero

Bachillerato universitario

Equipo medico

5 años de experiencia

Contrato Indefinido

801562

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