Sr. Quality Engineer

Medline; Mexicali; On-site; MXN 600,000 - 900,000; Full time

Job summary

Medline is seeking a Senior Quality Engineer at its MXC site to lead quality engineering initiatives focused on continuous improvement of both sterile and non-sterile products and processes. You will coordinate CAPA activities and collaborate with QC and Manufacturing Engineering to improve quality performance.

The role requires strong leadership, effective communication, and a self-driven mindset, with extensive experience in Medical Devices and regulatory knowledge including ISO13485 and

Qualifications

• Bachelor Degree in Engineering, Manufacturing, Industrial or related fields.
• Minimum 5 years of Quality Control/Engineering experience.
• Experience in Medical Devices.
• ASQ Certification (CQE) or Six Sigma a plus.
• Internal / Lead Auditor ISO 13485:2016.
• MDSAP knowledge.
• English: 90% proficiency.
• Office Windows: Word, Excel, PowerPoint.
• Strong leadership and effective communication.
• Self-driven with solid decision making.

Responsibilities

• Lead Quality Engineering functions and drive continuous improvement for sterile and non-sterile products and processes.
• Coordinate CAPA activities and partner with QC and Manufacturing Engineering.
• Ensure compliance with regulatory standards (ISO13485, MDSAP, 21CFR Part 820 FDA).
• Participate in internal audits and support external audits as required.

Skills

Leadership

Effective communication

Self-driven

Decision making

English proficiency

Education

Bachelor's Degree in Engineering/Manufacturing/Industrial

Tools

SAP

ETQ Reliance

AS400

Job description

The Senior Quality Engineer executes and coordinates Quality Engineering functions with a focus on continuous improvement of sterile and non sterile products and processes for MXC site. Leads the execution of initiatives and projects to enhance quality performance. Assures compliance to all applicable regulatory requirements and standards (ISO13485, MDSAP, 21CFR Part 820 FDA ). Partnering with QC and Manufacturing Engineering to manage continuous process/quality improvement programs, corrective and preventive (CAPA) activities in process as well as customer requirements. Participate in the internal audit program as Internal Auditor, support external audits (customer and third parties) as required.

• Bachelor Degree: Engineering, Manufacture, Industrial or related, Administration
• Minimum 5 years of Quality Control/Engineering experience
• Experience in Medical Devices
• ASQ Certification (CQE), Six Sigma Green Belt or Black Belt is a plus
• Internal / Lead Auditor ISO 13485:2016
• MDSAP knowledge
• English: 90%
• Office Windows: Word, Excel, Power Point
• Advanced SAP
• ETQ Reliance, AS400
• Strong leadership
• effective communication
• Self driven
• Management skills / Decision Making