Quality Manager

Job Description Summary

How about becoming a maker of possible?

For more than 125 years, we’ve pursued our Purpose of advancing the world of health. We relentlessly commit to a promising future by developing innovative technologies, services and solutions, helping the healthcare community improve safety and increase efficiency. It takes the imagination and passion of all of us at BD, from the manufacturing to marketing of our products, to look at the impossible and find transformative solutions to turn dreams into possibilities – For people today, tomorrow and beyond.

Become a maker of possible with us!

BD is one of the most recognized manufacturers of Medical Devices worldwide. The quality of our products is a benchmark for customers and end users of our products; the Quality area in our Plant strives daily to have systems that guarantee the reproducibility of our processes, compliance with applicable national and international legislation, and maintaining the world class standards that characterize us.

The Quality Manager is responsible for the management, direction, and coordination of all quality and regulatory compliance activities across the site in compliance with global regulations, business strategies, and customer needs. This includes providing quality leadership encompassing Quality Systems, Quality Engineering, metrology, and training to ensure required regulatory, quality, and production standards are achieved through cannula manufacturing and product release. He/she is active in the initiation, creation, implementation, and maintenance of plant-wide quality systems that ensure superior quality and continuous process improvement. Establish and implement programs designed to ensure control of processes and products that meet or exceed established standards and specifications. Informs Management of quality issues and solutions related to quality and regulatory compliance.

Job Responsibilities:

• Lead process improvement activities, using Six Sigma or Continuous Improvement techniques to reduce nonconformities or any other quality metrics established by the plant.
• Coordinate and facilitate quality improvement programs within the plant to achieve overall plant objectives.
• Take a leadership role in the analysis (root cause analysis) and resolution (action plan) of issues affecting quality.
• Implement and verify inspection methods to improve the detection of defects prior to shipping products to customers, maintaining studies available for all interested departments.
• Together with the business teams, plan balanced actions focused on compliance for the product manufacturing in relation to quality plans, validations, inspections, projects, and improvement activities. Collaborate with the production, engineering, maintenance, and continuous improvement departments.
• Prepare, update, and revise work instructions, procedures, and specifications as necessary.
• Lead activities focused on preparing for external and internal audits, and certification processes (as applicable), showing metrics to track progress.
• Formulate opinions and implement policies and procedures related to product quality and process control.
• Responsible for enforcing local, state, federal regulations and BD quality standards.
• Responsible for ensuring compliance of the quality system at the San Luis Potosí plant.
• Communicate regulatory changes, corporate procedures, or the Columbus plant to the San Luis Potosí plant.
• Manage, develop, and train the quality department’s human resources.
• Manage the Quality budget.
• Use, care, and safeguard the quality department's assets.
• Lead corporate initiatives at the San Luis Potosí plant, systematically and effectively communicating with the leadership team.
• Plan, report, and communicate KPIs within the plant, and to corporate.
• Establish high-impact individual annual objectives (IIG) for quality department associates.
• Audit suppliers.
• Authorize risk assessments for suppliers.
• Control and manage the quality system, which includes implementation of the CAPA system and its monitoring, implementation and control of the internal documentation system, implementation and control of the Validation system, implementation and monitoring of the process control system.
• Lead and develop plant QCs.
• Standardize the level of competence, attitudes, and criteria of the quality team.
• Develop, update, and maintain quality plans.

Education and Experience:

• Mechanical, Industrial Engineering, or related field.
• 8 years of experience in the Quality area, including supervisory experience.
• Advanced English.

“BD values equity in the workplace without discrimination for any disability, class, ethnicity, age, religion, gender identity or sexual orientation.”

Primary Work Location: MEX San Luis Potosi - Villa de Reyes