Quality Engineer I
On-siteCiudad Juarez, Estado de Jalisco, Mexico
Job Summary
Revise and analyze the effectiveness of PCDA, Six Sigma, Kaizen, and Lean techniques to drive process improvements. Revisit product and process compliance with QSRs, ISO 13485, and FDA regulations, including support during internal and external audits. Conduct line audits to evaluate GMPs, production controls, and lot segregation, ensuring corrective and preventive actions are adequate. Investigate non-conformities, customer complaints, and failure modes to determine root causes and implement risk mitigation strategies. Execute IQ, OQ, and PQ validations, maintain CTQs, and manage FMEA documentation for process risk. Supervise personnel, mentor team members, and ensure adherence to health, safety, and environmental guidelines.
Required Qualifications
- Bachelor's in engineering: Mechanical, Electrical, Industrial or applicable science
- 0 to 2 years of work experience or demonstrated performance
- Statistics knowledge
- Use of computer packages
- Ability to communicate in English, orally and in writing
- Knowledge of engineering fundaments
Desired Qualifications
- Knowledge of the Product Risk Management / process (FDA and ISO regulations)
- Ability to perform 'active involvement' in the solution of problems and resolution problems
- Capacity to solve problems by providing good judgment
- CQA certification
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