Descripción y detalle de las actividades
POSITION SUMMARY:
Ensure compliance with quality systems (ISO *****, FDA QSR) during production processes.
Apply engineering/technical skills, six sigma and/or lean manufacturing methodologies to make recommendations and carry out Quality improvements with the Design, Manufacturing and Quality of the products and services offered to customers.
Perform product validations, process validations and equipment qualifications to maintain FDA compliance as applicable.

MAIN RESPONSIBILITIES
Provide Quality review for product design changes.
Review Design History Files (DHF) for accuracy and compliance to internal and regulatory (FDA) requirements.
Evaluate and investigate customer complaints: Includes failure analysis and resolution through an electronic system.
Generate statistical reports on quality performance in the process and in the product: Review quality data trending to determine if action(s) need to take place.
Execute CAPA (Corrective and Preventive Action) tools as required, both internally and externally, to bring about the desired changes and continuous improvement
Represent Quality on various teams, including ISO and/or FDA Audits, providing data information as needed, including internal audits.

Experiencia y requisitos
REQUIRED SKILLS, KNOWLEDGE AND EXPERIENCE
Engineer ( Industrial, Mechanical ) minimum of five years of quality or related discipline and/or equivalent combination of education and related experience
Strong Communication Skills (both written and verbal) Spanish and advanced English (MIN 85%)
Knowledge of quality systems: ISO *****, 21 CFR 820
Experience with Risk Assessment tools such as HARMs, FMEA, MRB, CAPA, required.




Knowledge of methodologies: Lean Manufacturing, APQP, FMEA, SPC
Strong working knowledge of computer database systems, Microsoft applications, PC, and various software programs required.
Strong aptitude for problem solving, root cause analyses, and an understanding of dynamic mechanical assemblies desired.
Capable to present data (presentations) to management teams and train co-workers as needed.
Must have ability to properly interpret Engineering drawings and clearly present that information to others.
Ability to travel to other facilities to support quality audits and/or issues may be required.

COMPETENCIES REQUIRED
Analytical Thinking - Confront a problem using a logical, systematic, and sequential approach
Results orientation - Focus on the desired end result of oneself or of the team. Establish challenging goals, focusing efforts on meeting or exceeding objectives.
Prevention and problem solving - Visualize the future anticipate the implications and consequences of situations. Take the appropriate measures to be prepared for possible emergencies.
Customer orientation- Worry about the satisfaction of external and internal customers.
Oral Communication – Expressing oneself clearly in conversations and interactions with others.
Written Communication – Expressing oneself clearly in business writing.
-Diagnostic Information Gathering – Identifying the information needed to clarify a situation, seeking that information from appropriate sources, and using skillful questioning to draw out the information.

Beneficios
Beneficios de acuerdo a la LFT
Protegido de gastos médicos
Uniforme
Servicios medicos en planta
Comedor

📌 Quality Engineer (Tijuana)
🏢 Sunrise Medical Tecnologías, S.A. de
📍 Tijuana