** Position**: Quality Engineer
- **Salary**: $50,000 MXN gross per month
- **Schedule**: Monday to Friday, 7:00 am - 5:30 pm
- **Work Model**: On-site
- **Location**: Tijuana, Baja California
- **Project Duration**: 6 months
**_ Main Functions:_**
- Ensure compliance with QSR part 820, ISO-13485 and other applicable regulations.
- Ensures and reports on metrics to monitor quality performance.
- Ensure that the non-conforming material process is executed in accordance with established procedures and in compliance with determined metrics.
- Support with the creation, maintenance and where applicable improvement of work instructions
- Support with validation activities, IQs, TMVs, OQs, PQs, for designated areas.
- May lead or participate in NCR, SNCR, CAPA activities in accordance with established procedures and ensuring compliance with quality objectives.
- Assists management and departmental staff in the implementation of statistical quality control techniques in order to improve operational efficiency and effectiveness.
- Responsible for the analysis of data obtained from the field to investigate and resolve issues identified through Post Market Surveillance Report.
- Participates in project transfer, through the identification and correcction of gaps identified in the manufacturing processes, establishing product acceptance criteria, ensuring quality controls and supporting project deadlines.
- Participates in Value Stream projects (quality improvements,



cost savings, productivity gains).
- Ensure that all inspection and test specifications are properly performed and documented.
- Conduct a root cause analysis to prevent recurrence.
- Supervise and coordinate the function of the Quality Technicians and Quality Intern.
- Conducts routinary internal audits, Gembas, LTTs of the quality system in compliance with procedures. Reports audit results to management.
- Ensures compliance with assigned KPIs and notifies management of any possible impact.
- Supports analysis, investigation and field actions. Creates consignees list and contacts clients to obtain required information.
**_Requirements:_**
- Bachelor's degree.
- Excellent verbal and written communication skills (English/Spanish).
- Personnel Management.
- Training - Knowledge on risk management ISO13485 and ISO 14971. QSR Part 820 e ISO13485 / QSR Part 820 and ISO13485 Training / Awareness.
- Formal education or training in quality control techniques, including quality system audits, statistical tools, design of experiments, statistical sampling methods and testing methods, Lean principles, etc.
- Inglés Avanzado.
**_ We offer:_**
- **
- Statutory Benefits** (Prestaciones de ley).
- **Life Insurance.**
**Kelly is an equal opportunity employer.** We foster a diverse and inclusive work environment where all individuals are valued and respected.

📌 Quality Engineer (Tijuana)
🏢 Kelly Services de México
📍 Tijuana