PUESTO CERRADO
Coyol Free Zone
| Publicación | 2022-03-11 |
| Finalización | 2022-03-31 |
| Tipo Vacante | Vacante |
Quality Engineer
QualityWorks closely with Manufacturing and Engineering on sustaining activities to ensure compliance with the quality system requirements and achievement of Key Performance Indicators (i.e. NCMR’s, MA’s, Yield, Cost Reduction projects, etc.) and support/owns process/product validation activities.
Works closely with Research and Development and Regulatory Affairs personnel (internal or external) to obtained support on sustaining activities and during new product introduction to assure compliance with product and regulatory requirements.
Support of Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) and audits (External / Internal).
Roles y Responsabilidades
• Verify company’s adherence to the established Quality System and GMP/ISO standards.
• Completion of risk management and risk analysis including FMEA. Also, provide mentorship to lower level engineering positions.
• Work with R&D/Design Quality to revise design verification and design validation plans for products based on performance specifications and risk analysis. Also, provide mentorship to lower level engineering positions.
• Supports technical and statistical investigations concerning optimization and compliance to specification. Also, provide mentorship to lower level engineering positions.
• Owner of measuring process capability, process controls, and process validation / efforts.
• Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
• Conducting NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process.
• Completing and Documenting Monthly Quality Data Review, providing data analysis and escalation recommendations
Educación / Experiencia
- Bachelor’s degree in Industrial Eng, Chemistry Eng, Material Eng, Microbiology Eng or similar careers.
- At least 4 years of experience in Quality or Engineering positions.
- Advanced english level
- Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
- Knowledge of statistical/data analysis and report writing experience.
- Experience with control of nonconforming material, corrective and preventive actions as investigation owner and/or implementor.
- Detailed knowledge of FDA, GMP, and ISO 13485.
- Experience on External and Internal audits.
- Experience on product and process qualification and validation.
Habilidades y Competencias
• Experience with SAP.
• ASQ CQE / Six Sigma or similar certification.
• Participation or leading multi-departmental project teams.
• Experience in supervision role.