Quality Engineering Manager - Lead NPI & Improvement

Becton Dickinson; Nuevo León; Sur place; MXN 900 000 - 1 300 000; Plein temps

Résumé du poste

Becton Dickinson (BD) is seeking an experienced Quality Assurance leader to guide a team of quality engineers through the full product lifecycle, from NPI to commercialization. You will ensure design validation, risk management, and process validation align with the QMS and regulatory requirements.

You will oversee disposal decisions for non-conforming products, manage change controls, and support audits and senior management reviews.

Qualifications

• Bachelor’s degree in engineering or sciences.
• Minimum 5 years in a medical device company or high-volume regulated manufacturing.
• Minimum 5 years in QA roles with decision-making or leadership.
• ASQ-CQE certification desirable.
• Lean Six Sigma Green Belt certification or higher desirable.

Responsabilités

• Lead a team of quality engineers to support the entire product lifecycle, ensuring quality requirements are defined and implemented during the NPI and transfers.
• Oversee disposal decisions (use-as-is, rework, scrap) with risk assessment and QMS compliance.
• Plan and coordinate quality engineering activities to meet plant KPIs.
• Guide statistical analyses (DOE, Gage R&R, hypothesis testing) for process development and validation.
• Manage site validation program, IQ/OQ/PQ activities, and validation status of processes and equipment.
• Support audits, management reviews, and quality metrics reporting.
• Drive continuous improvement to enhance process capability and data reliability.

Connaissances

Quality Assurance

DOE

Gage R&R

Process validation

CAPA

Regulatory compliance

Leadership

Risk management

Formation

Bachelor’s degree in engineering or sciences

ASQ-CQE certification desirable

Lean Six Sigma Green Belt desirable

Outils

QMS

Description du poste

Becton Dickinson (BD) is seeking an experienced Quality Assurance leader to guide a team of quality engineers through the full product lifecycle, from NPI to commercialization. You will ensure design validation, risk management, and process validation align with the QMS and regulatory requirements.

You will oversee disposal decisions for non-conforming products, manage change controls, and support audits and senior management reviews.