Senior Quality Engineer

Forjas Y Maquinas, S. De R.L. De C.V.; Aguascalientes; Presencial; MXN 30,000 - 50,000; Jornada completa

Descripción de la vacante

A leading company in the manufacturing sector seeks a Quality Engineer responsible for ensuring product quality throughout the lifecycle. Ideal candidates will have extensive experience in quality engineering, particularly in medical devices, and possess strong analytical skills and knowledge of quality management frameworks.

Formación

• Minimum 8+ years in Quality Engineering and Manufacturing Engineering, 4 years in medical device.
• Proficiency in Lean & Six Sigma methodologies required.
• Experience with ISO 17025 and quality statistical tools essential.

Responsabilidades

• Define and monitor corrective actions to reduce supplier rejections.
• Conduct on-site assessments to boost supplier performance.
• Provide technical support for validations and statistical analysis.

Conocimientos

Lean & Six Sigma tools (DMAIC, PDCA)

Metrology

ISO 17025 requirements

Quality Statistical Tools

English proficiency

Educación

Bachelor’s degree in Electrical, Mechanical, or System Engineering, Math, or Physics

Advanced degree preferred

Herramientas

Microsoft Office

APQP

PPAP

VDA 6.3

MSA

Descripción del empleo

Description

Responsible for ensuring the quality of products or processes throughout their development lifecycle

Skills, Experience, Education, & Training

• Minimum Education: bachelor’s degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred.
• Proficient in English. Ability to communicate efficiently is a must.
• Minimum 8+ years of working experience in Quality Engineering and Manufacturing Engineering, in manufacturing environment, minimum 4 years in medical device design or manufacturing environment.
• Lean & Six sigma tools such as DMAIC or PDCA
• Metrology & ISO 17025 Requirements
• MSA
• APQP, PPAP, VDA 6.3, Microsoft Office

Key Responsibilities

• Definition and monitoring of corrective and preventive actions to reduce supplier rejections.
• Define characteristics and methods based on specification to perform inspections on the receipt of material.
• Establishment of improvement programs with suppliers, as well as their follow-up.
• Conduct on-site assessments and supplier support visits to improve supplier performance and achieve company objectives in the areas of Quality, Cost, and Response. These activities include control plan audits, product audits, resolution activities for problems encountered at the plant.
• Review the supplier's component design to ensure they meet specified tolerances.
• On-site verification of capacity and implementation of EPC process.
• Management of the supplier improvement system.
• Application of quality statistical tools.
• Evaluate the supplier's machinery and equipment to determine repair and replacement needs.
• Generation of quality complaints to suppliers and follow-up to closing through 8D.
• Development of plans for line and capacity specifications as needed. Check that the component specifications are in accordance with the drawings
• Provides technical support to Manufacturing and Product Engineering regarding validations, test method validations, and statistical analysis.
• Supports the planning, development, implementation and maintenance of manufacturing methods, processes and operations for new and existing products as well as the design and manufacturing of new tooling and equipment.
• Involvement in continuous improvement projects (Kaizens, Transfers, etc.)
• Reject or approve material based on its compliance