QA Engineer

Medline; Mexicali; Híbrido; MXN 279.000 - 469.000; Jornada completa

Descripción de la vacante

Medline Industries, LP in Mexicali is seeking a QA Engineer to lead CAPA activities, perform PFMEA reviews, and ensure GMP compliance across manufacturing and packaging operations in a hybrid role. The position requires a Bachelor’s degree in Manufacturing or Industrial Engineering and 1–3 years ofQuality Control/Engineering experience within medical devices, plus ISO 13485:2016 auditing exposure.

Fluency in English is essential.

Formación

• Bachelor's degree in Manufacturing, industrial engineering or a related field.
• 1-3 years of Quality Control/Engineering experience.
• Experience with Medical Devices and ISO 13485:2016 internal/lead auditing is required.

Responsabilidades

• Lead and coordinate CAPA for customer complaints and process non-conformities.
• Communicate product quality issues, data analysis, trends to internal customers.
• Continual process reviews via PFMEA documents.
• Develop processes to identify trends and focus on customer complaints and in-process non-conformances.
• Define measurement equipment to evaluate inspections.
• Define effective control plans for warehouse to operations delivery of raw materials.
• Lead continuous improvement projects focused on quality and cost reductions.
• Perform periodic audits of storage locations and communicate results to warehouse personnel.
• Support GMP implementations and improvements.
• Maintain communication with peers, internal customers, suppliers and management on progress.

Conocimientos

Bilingual (English)

Effective communication

Team collaboration

Self-motivated

Lean manufacturing

Six Sigma

Quality focus

Educación

Bachelor's degree in Manufacturing, industrial or related field

Descripción del empleo

## QA EngineerApply: Hybrid: Mexicali, Baja California: Full time: Posted Today: R2610486**Job Description****Responsibilities:*** Lead and coordinate Corrective and Preventive Actions (CAPA) for Customer complaints, and process non-conformities.* Communicate product quality issues, data analysis, trends, and/or other information to respective internal customers.* Continual process reviews through the use of the defined process failure mode analysis (PFMEAs) documents.* Develop processes and plans to identify trends and focus on customer complaints, and in-process non-conformances.* Develop and define measurement equipment to evaluate and perform component inspections.* Define effective control plans for warehouse to operations delivery of raw materials’ processes.* Define, and lead continuous improvement projects focused on quality improvement, and cost reductions.* Perform periodic audits of the accuracy and cleanliness of component storage locations and communicate results with appropriate warehouse personnel.* Support the implementation and improvements for Good Manufacturing Practices (GMPs).* Practice effective communications with peers, internal customers, suppliers and management on progress of activities.* Maintain effective communication with Corporate counterparts.**Education:*** Bachelor's degree in Manufacture, industrial or related degree to the position and responsibilities listed above**Work Experience**:* 1-3 years of Quality Control/Engineering experience* Medical Devices Experience (pharmaceutical, food or personal Care)* Internal / Lead Auditor ISO 13485:2016**Knowledge / Skills / Abilities*** Bilingual (Fluent in English).* Effective communication* Able to collaborate effectively and respectfully with teams* Acts as a team member and facilitator* Self-motivated, demonstrated bias for action.* Lean manufacturing, Six sigma BB. GBMedline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.