Quality Engineering Manager — Lead NPI & Process Validation

BD; Ciudad Juárez; On-site; MXN 900,000 - 1,300,000; Full time

Job summary

BD is a leading global medical technology company focused on advancing health. The role leads a team of quality engineers, guiding QA activities across the product lifecycle, including design validation, process validation, and continuous improvement at the Juárez site.

You will ensure compliance with QMS, manage non-conformances and CAPAs, and interact with cross-functional teams to drive quality metrics and regulatory readiness.

Qualifications

• Bachelor’s degree in engineering or sciences or equivalent technical degree.
• Minimum 5 years in a medical device company or high-volume regulated manufacturing environment.
• Minimum 5 years in Quality Assurance roles with impact on decision-making or supervision/leadership.
• ASQ-CQE certification is desirable.
• Lean Six Sigma Green Belt certification or higher is desirable.

Responsibilities

• Lead a team of quality engineers to support the entire product lifecycle, ensuring quality requirements are defined and implemented during NPI and design validation, risk management, and process validation.
• Oversee disposal decisions for non-conforming products in accordance with QMS and regulatory requirements.
• Plan and coordinate quality engineering activities to meet plant KPIs.
• Support statistical analyses (DOE, Gage R&R, process capability, etc.) for process development and validation.
• Manage site validation program including IQ/OQ/PQ activities and revalidations.

Skills

QA leadership

Regulatory awareness

Education

Bachelor’s degree in engineering or equivalent technical degree in sciences

ASQ-CQE certification

Lean Six Sigma Green Belt or higher

Job description

BD is a leading global medical technology company focused on advancing health. The role leads a team of quality engineers, guiding QA activities across the product lifecycle, including design validation, process validation, and continuous improvement at the Juárez site.

You will ensure compliance with QMS, manage non-conformances and CAPAs, and interact with cross-functional teams to drive quality metrics and regulatory readiness.