Supplier quality engineer


Salario confidencial CRC

Toda Costa Rica

Publicado 21 Jul 2021

Logística / Distribución / Otras

1 Vacante

Ingeniería Industrial

Sector de la vacante:
Industrias manufactureras

Descripción general

SUMMARY: Performs planned and unplanned Internal and supplier audits to verify compliance to applicable government regulations, standards and to company policies and procedures. Maintains Supplier Quality requirements and supports Quality Systems within Confluent Medical such as Training, Customer audits and Document Control. Recommends improvement to quality systems based on assessments performed. Provides compliance guidance to the organization as required including guidance to lower level personnel. Exercises judgment within defined procedures and practices to determine appropriate action. Participates in decisions on scope of work and length of tasks. Writes, reviews, documents, and implements requirements. Provides and develops solutions to problems. Works independently on routine tasks and needs supervision to resolve some complex issues. Supports administration of the SCAR and CAPA system.
EDUCATION and/or EXPERIENCE: Bachelor degree in engineering discipline; 3-4 years of related experience and/or training. Work requires a broad knowledge of precedents in the specialty area and a good knowledge of principles and practices of relates specialties. Experience and knowledge in Process Validation in the Medical Device Industry would be an important asset. Knowledge of audit and statistical techniques is a must.

Requisitos para aplicar

ESSENTIAL DUTIES AND RESPONSABILITIES include the following. Other duties may be assigned.
? Performs planned, internal and supplier audits of product and service suppliers for compliance to applicable government and international regulations and company procedures.
? Assures that the supplier quality system audit function complies with QSR/GMP and ISO requirements.
? Assigns actions or Corrective actions for deficiencies as needed and required.
? Assigns classifications and documents audit results in written audit reports.
? Can serve as lead auditor, leading a team of auditors, technical experts and auditors-in-training.
? Performs Supplier Module administration for ETQ Reliance software.
? Work with Supply Chain department to maintain supplier profiles up to date
? Subject Matter Expert for Supplier Management QSE section
? Reviews audit responses and assists with required training in response to audit findings and other GMP/QSR/ISO related issues as needed.
? Periodically collects compliance metrics and generates data for management reviews.
? Maintains abreast of regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings.
? Responsible for following all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
? Support Regulatory Affairs processes, including submission of product 510K and Design Dossier.
? Works with supply chain to ensure Supplier Change Notifications are implemented as planned in Confluent´s system

Datos complementarios




Bachillerato universitario

Equipo medico

4 años de experiencia

Contrato Indefinido


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