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Responsible to ensure that products released at the different production stages meet all predetermined requirements, and production activities are performed in regulatory compliance per FDA 21 CFR part 820 and ISO 13485:2016. Contributes and participates in the activities required to achieve the quality performance metrics and guarantee the continuous effectiveness of the QMS.
· Lead, participate and contribute to achieve the quality performance metrics.
· Follow up with owners of CAPAs, NMRs, Customer Complaints to ensure these are addressed on a timely manner.
· Ensure production activities meet the Regulatory Compliance with FDA 21 CFR part 820, ISO-13485:2016.
· Provide support to other departments to develop and implement cost saving projects, scrap reduction projects and quality improvement projects.
· Perform Internal Audits and provide support on external audits.
· Develops, modifies and maintains updated the quality system documentation.
· Reviews the performance of subordinates and recommends the training plans.
· Provide support for the introduction and transfer of new products and /or processes validation.
· Generates, analyze and present quality metric reports on daily basis.
· Lead investigation of customer complaints and coordinates with other departments the implementation of corrective actions.
· Escalate nonconformances related to raw materials, follow up with suppliers to resolve the quality issues.
· Ensure the proper implementation of the calibration system.
· Provide training to inspectors, technicians and /or personnel from other areas, on the final product, processes, equipment, etc.
Education:
Bachelor's degree on either Industrial Engineering, Chemical Engineering, Biomedical Engineering.
Experience:
3 to 5 years of experience as Quality Engineer in the medical industry. Previous experience in process and equipment validation (IQ, OQ, PQ) and test method validation (TMV).
Skills
- Teamwork, proactive, responsible, and organized.
- Supervision of personnel
- Use of Microsoft Office package (Word, Excel, Power Point, Outlook).
- Knowledge on ISO 13485:2016 and 21 CFR 820 regulations
- Knowledge of statistical tolos (Cpk, Pareto, Hypothesis test, GR&R), problem solving techniques (8D, PDCA, Ishikawa, 5 Why), risk analysis tools (FMEA)
- Validation of inspection, measuring and test equipment (TMV).
Tipo de puesto: Tiempo completo
Sueldo: $1.00 a la semana
Beneficios:
- Opción a contrato indefinido
- Vales de despensa
Lugar de trabajo: Empleo presencial
