Quality Engineering Leader - MedTech Process Excellence

BD; Juarez; On-site; MXN 900,000 - 1,200,000; Full time

Job summary

BD is a global medical technology company committed to advancing health. We seek an experienced Quality leader to manage a team of quality engineers supporting the full product lifecycle, including NPI and design validation, risk management, and process validation to readiness for commercialization.

The role drives transfer activities, change control, and data integrity within a robust QMS framework. The candidate will oversee site validation, CAPA and statistics-based process development, while

Qualifications

• Bachelor’s degree in engineering or equivalent technical degree in sciences.
• Minimum 5 years of experience in a medical device company or in a high-volume regulated manufacturing environment.
• Minimum 5 years of experience in Quality Assurance roles with impact on decision-making and/or in supervision/leadership or other related functions.
• 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 that quality requirements are defined and implemented during the NPI, including design validation, risk management, and process validation to achieve readiness for commercialization; leading quality activities in product and process transfers ensuring equivalence, validation and alignment with the QMS; provide oversight of support activities through effective change control, performance monitoring, and continuous improvement; maintain compliance with SIB initiatives by managing revalidations and ensuring documentation accuracy and data integrity.
• Ensure the proper disposal of non-conforming products, through technical review and approval of disposal decisions (use-as-is, rework, sort, or scrap), ensuring compliance with Quality Management System (QMS) procedures, regulatory requirements and assessment of associated risks.
• Plan and coordinate quality engineering activities and resource requirements according to the goals and needs of the plant to meet established KPIs.
• Ensure that Quality Engineers support, develop, and review, as appropriate, statistical analyses, including process capability studies, Design of Experiments (DOE), hypothesis testing, Gage R&R, regression analysis, and other applicable techniques, to enable effective process development and validation activities
• Manage the site validation program, as well as the personnel in charge of it (Site Validation Lead), including resource allocation, prioritization of IQ/OQ/PQ activities, periodic revalidations, and ensuring the validity of the validated status of processes, equipment, software, and testing methods.
• Provide support to other multidisciplinary functions within the organization and approve validation activities (IQ/OQ/PQ, process validation, software and testing methods).
• Maintain a comprehensive view on the plant floor of the processes that generate product quality problems, initiate corrective actions when necessary, and follow up on complaints and quality rejections.
• Interact with intercompany areas, business units (BUs), Legal, Manufacturing, Quality and Regulatory Affairs: evaluate products returned for alleged non-conformity.
• Provide support during internal and external audits
• Prepare and provide support for Management Review meetings and other formal quality forums, ensuring accurate reporting, data analysis, and effective communication of performance and quality metrics.
• Lead continuous improvement initiatives to increase the effectiveness and efficiency of the Quality function through the implementation, standardization and optimization of inspection technologies, ensuring improvements in process capability, data reliability and operational performance.
• Lead the customer complaints area, ensuring DHR investigations, review of product risk documentation, and timely responses. Ensure that quality technicians/engineers analyze customer complaint trends to initiate CAPAs when necessary
• Promote a culture of quality in the Juárez area, Implement and promote quality initiatives in support to Business excellence programs

Skills

Quality Assurance

NPI support

Statistical analysis

Process validation

Change control

Education

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

ASQ-CQE certification desirable

Lean Six Sigma Green Belt desirable

Tools

DOE

Gage R&R

CAPA

Job description

BD is a global medical technology company committed to advancing health. We seek an experienced Quality leader to manage a team of quality engineers supporting the full product lifecycle, including NPI and design validation, risk management, and process validation to readiness for commercialization.

The role drives transfer activities, change control, and data integrity within a robust QMS framework. The candidate will oversee site validation, CAPA and statistics-based process development, while