QA Engineer

Medline; Mexicali; Ibrido; MXN 240.000 - 360.000; Tempo pieno

Descrizione del lavoro

Medline Mexicali is seeking a QA Engineer to lead CAPA activities for customer complaints, address non-conformities, and support GMP compliance in a hybrid work environment. You will analyze quality data, perform PFMEAs, develop measurement equipment and control plans for warehouse to operations, and drive continuous improvement projects in a manufacturing setting.

Required: Bachelor's in Manufacturing or Industrial Engineering and 1–3 years in quality control/engineering, with medical device

Competenze

• Bachelor's degree in Manufacturing, industrial or related field.
• 1–3 years of Quality Control/Engineering experience.
• Internal/Lead Auditor ISO 13485:2016 experience.

Mansioni

• Lead and coordinate CAPA for customer complaints and non-conformities.
• Communicate product quality issues, data analysis, trends to internal customers.
• Perform PFMEAs and continual process reviews to improve quality.
• Develop plans to identify trends in customer complaints and in-process non-conformances.
• Develop measurement equipment to evaluate component inspections.
• Define control plans for warehouse-to-operations delivery of raw materials.
• Lead continuous improvement projects focusing on quality and cost reduction.
• Audit component storage accuracy and communicate results to warehouse personnel.
• Support GMP implementation and improvements.
• Communicate progress with peers, internal customers, suppliers and management.
• Maintain communication with Corporate counterparts.

Conoscenze

CAPA management

Quality data analysis

PFMEA

Documentation & audits

Continuous improvement

Formazione

Bachelor's degree in Manufacturing/Industrial Engineering

Descrizione del lavoro

## 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.