Quality engineer


¢ 1 a 1,5 millones CRC

Toda Costa Rica

Publicado 10 Sep 2019

Operaciones / Otras

2 Vacantes

Ingeniería Industrial / Otras

Empresa confidencial

Sector de la vacante:
Industrias manufactureras

Descripción general

This person will provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Plan and execute actions to ensure the Quality System and Regulations/standards (EN/ISO 13485/MDD, GMPs, FDA QSR (820.20)) compliance within the entire organization. Work with corporate team to ensure the correct execution of validation of products/processes. Support internal/external audits, vendor qualification and training programs. Participate in or lead Corrective/Preventive Action initiatives.

Main duties
1. Investigate customer complaints, vendor and internal non conformances. Perform root cause analysis; determine corrective action and verification of effectiveness.
Assure Corrective and Preventive Action plans are developed and executed.
2. Assist in the coordination of continuous improvement processes for the quality system.
3. Create and modify current procedures and instructions.
4. Develop and analyze statistical data and product specification to determine standards and to establish quality expectancy of products.
5. Validate new equipment or processes.(IQ/OQ/PQ)
6. Conduct training for personnel to ensure compliance to company procedures.
7. Prepare and present technical and program information to team members and management.
8. Perform internal audits within the company to ensure compliance to applicable regulatory and corporate standards/requirements and ISO.
9. Communicate significant issues or developments identified during quality assurance audits and recommend process improvements to the Quality Manager.
10. Prepare reports to communicate quality metrics.
11. Maintain a working knowledge of government and industry quality assurance standards.
12. Function as a resource for matters related to the Quality System.
13. Improvements that minimize the Costs of Quality, specifically Rejects, Failures, and Factory defects

Requisitos para aplicar

Education and Experience

ISO9000/ISO13485) and CQE Certification

Experience: 4 years experience and one year experience in similar positions.

Language: Bilingual English / Spanish

Knowledge of Microsoft Office

Knowledge in problem-solving techniques

Knowledge of job requirements in medical industry (FDA regulations)

Knowledge of statistical tools, quality and reliability software

Knowledge of spreadsheets, databases, Process Control & Monitoring (SPC)

Experience in process improvement, Six Sigma, product and process qualification and validation

Detailed knowledge of FDA, GMP, and ISO 13485.

Experience in new product transfer.

Knowledge of measuring instruments, sampling plans.

Datos complementarios



Ingeniero / Otras

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6 años de experiencia


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