Ingeniero de Calidad Sr.

Quasar Medical Tecate S.A. de C.V.; Tecate; Presencial; MXN 696.985 - 1.045.478; Jornada completa

Descripción de la vacante

Quasar Medical Tecate S.A. de C.V. is looking for an experienced Sr. Quality Engineer to provide solutions for various technical problems within a medical device environment. The role requires a Bachelor's Degree in Engineering, with a graduate degree considered a plus, and 5-7 years of relevant experience.

The ideal candidate will lead projects, conduct audits, and ensure compliance with quality standards including ISO 13485 and FDA regulations. Strong knowledge of lean and six sigma tools is essential.

Formación

• 5-7 years related experience, preferably in medical device.
• Ability to lead projects under general supervision.
• Experience with sound conclusions based on available data.

Responsabilidades

• Provide solutions to a variety of technical problems.
• Connect tasks to the completion of milestones in projects.
• Ensure soundness of technical judgment and overall adequacy.

Conocimientos

MS Office suite

Project Minitab

FMEA ISO 14971

Lean tools

Six sigma tools

Blueprint reading

GD&T

Educación

Bachelor’s Degree in Engineering

Graduate degree

Herramientas

Controlled environment per ISO 14644-X

Knowledge of ISO13485 requirements

Metrology

ISO 17025 Requirements

FDA 21CFR:820 Requirements

QMS Auditor

Descripción del empleo

Experienced and skilled degreedengineer that provides solutions to a variety of technical problems of moderatescope and complexity. They typically will connect to tasks or to the completion of milestones of projects. Sr. Quality Engineer can lead projects with support and direction. Sr Quality Engineer understand available resources and use them appropriately.

works under general supervision and follow established procedures as her/his work is reviewed for soundness of technical judgement, overall adequacy, and accuracy. Failure to achieve results or erroneous decisions/recommendations may cause delays in schedules and may require additional resources. Sr. Quality Engineer is responsible for making sound conclusions based on available data.

• Bachelor’s Degree in Engineering from an engineering technology accredited programs.
• Graduate degree a plus
• 5-7 years related experience, preferably in medical device
• MS Office suite & Project Minitab FMEA ISO 14971 GMP
• Controlled environment per ISO 14644-X
• Knowledge of ISO13485 requirements
• Lean & Six sigma tools such as DMAIC or PDCA
• Metrology & ISO 17025 Requirements
• MSA Blueprint reading and/or GD&T
• FDA 21CFR:820 Requirements
• QMS Auditor