Quality Engineer

At Kelly, we are dedicated to connecting talent with the world of work in ways that enrich their lives, and connecting companies with talented individuals who drive innovation and growth. With over 78 years of global experience and 29 years in Mexico, we are leaders in specialized solutions for human resources, operational, and administrative process outsourcing. kellyservices.com.mx.

• 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.