Quality Engineer II — Medical Device Validation & Risk

Owens & Minor; México; On-site; MXN 360,000 - 600,000; Full time

Job summary

Owens & Minor in Mexico is seeking a Quality Engineer II to support quality engineering across new-product development, design controls, risk management, validation, and post-market activities. You will collaborate with cross-functional teams to ensure compliant product development and continuous improvement.

The role requires a Bachelor’s degree and 3+ years in a medical-device or similarly regulated setting, with strong analytical and problem-solving skills and proficiency in MS Office.

Qualifications

• Bachelor’s degree in Engineering, Microbiology, Sciences, Quality, or related field.
• 3+ years of progressive Quality Engineering or related experience in regulated environments.
• Experience with design controls, risk management, process validation, change control, and quality systems.

Responsibilities

• Support validation activities for manufacturing, distribution, product changes, and process changes.
• Assist in product development, change control, and regulatory documentation.
• Contribute to risk management activities and maintain quality records.
• Participate in investigations, root-cause analysis, and corrective actions.
• Assist in audits by providing documentation and quality records.

Skills

Analytical skills

Problem-solving

Cross-functional

Documentation

Independent work

Attention to detail

Education

Bachelor’s degree (Engineering/Quality)

Tools

MS Office

Job description

Owens & Minor in Mexico is seeking a Quality Engineer II to support quality engineering across new-product development, design controls, risk management, validation, and post-market activities. You will collaborate with cross-functional teams to ensure compliant product development and continuous improvement.

The role requires a Bachelor’s degree and 3+ years in a medical-device or similarly regulated setting, with strong analytical and problem-solving skills and proficiency in MS Office.