Quality Engineer

Sunrise Medical Tecnologías, S.A. de C.V.; Tijuana; Presencial; MXN 732,000 - 1,099,000; Jornada completa

Descripción de la vacante

A leading medical technology company in Tijuana is looking for a Quality Engineer to ensure compliance with quality systems and enhance product quality. The ideal candidate has at least five years of relevant engineering experience, strong communication skills in Spanish and English, and is adept at problem-solving and root cause analysis. This position offers the opportunity to work with cutting-edge medical technologies.

Formación

• Minimum of five years of quality or related discipline experience.
• Experience with Risk Assessment tools such as HARMs, FMEA, MRB, CAPA.
• Strong working knowledge of computer database systems required.

Responsabilidades

• Ensure compliance with quality systems during production processes.
• Provide Quality review for product design changes.
• Generate statistical reports on quality performance.

Conocimientos

Strong Communication Skills (Spanish and English, 85%)

Problem solving and root cause analysis

Analytical Thinking

Customer orientation

Educación

Engineer (Industrial, Mechanical)

Herramientas

Microsoft applications

Quality systems (ISO 13485, 21 CFR 820)

Descripción del empleo

POSITION SUMMARY:

• Ensure compliance with quality systems (ISO 13485, 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.

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 13485, 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.