Regional Quality Director (Mexico)

COMPANY DESCRIPTION

At AirLife, we are dedicated to improving the quality of every breath. Excellence with Every Breath is not just a tag line, but the way we work and take care of our customers. With a mindset to evolve, innovate, and grow, we are a premier manufacturer of the highest-quality and market-leading breathing consumables. This growth philosophy has positioned us to increase our global footprint and business reach, impacting even more people around the world. Our expanding family of the most trusted brands offers a product portfolio that spans the continuum of care from first responder to home care, with safety, patient comfort, and clinical performance in mind. Collective expertise allows us to provide quality products and experiences to our patients, customers, and our people. Our values of Customer first, Differentiate with our People, Bias for Action, Continuous Improvement and Accountability define who we are and how we work. Join us!

POSITION SUMMARY

The Regional Manufacturing QA Leader is responsible for overseeing and ensuring the implementation and standardization of the Quality and Compliance Management System across five manufacturing sites in three states in Mexico. This role ensures that all processes adhere to applicable regulations in the medical industry and meet AirLife customer expectations. The manager will focus on standardizing and optimizing processes, methods, and criteria, while leveraging best practices across all sites.

POSITION QUALIFICATIONS

Knowledge

• Medical Manufacturing Processes: Understanding of medical production processes, from raw materials to finished products.
• Change Management: In-depth knowledge of strategies for implementing organizational changes while maintaining quality and productivity standards.

Competencies

• Leadership: Proven ability to lead and motivate quality teams across multiple locations, fostering collaboration and adherence to standardized quality processes.
• Effective Communication : Strong communication skills in both English and Spanish, capable of interacting across all levels of the organization, from plant operators to senior executives.
• Remote Team Management: Experience managing teams across various locations, ensuring consistent alignment with quality standards and processes.
• Results-Oriented: Demonstrated focus on achieving quality objectives, reducing waste, and meeting key performance indicators (KPIs).
• Team Player: Ability to negotiate, delegate, and collaborate effectively across teams.
• Change Management: Strong capability in leading transformation initiatives, ensuring successful adoption of new processes, technologies, and quality procedures with minimal disruption.
• Analytical Thinking: Proficient in analyzing complex data to solve problems and improve quality operations.
• Adaptability: Ability to adjust to diverse regional regulations, market demands, and customer expectations.

Skills

• Project Management: Expertise in planning, executing, and overseeing continuous improvement projects across multiple sites.
• Medical Regulations and Quality Standards: Deep knowledge of ISO 13485, MDSAP, COFEPRIS Standards and Rules in Mexico, Six Sigma, Lean Manufacturing, and other relevant certifications. Interest in gaining knowledge of international regulations and standards for products manufactured in Mexico and sold internationally.
• OpEx/Continuous Improvement: Capable of identifying areas to improve quality, reduce costs, and increase efficiency.
• Interpersonal Skills: Strong ability to build relationships with cross-functional teams, suppliers, and customers.
• Change Management: Competence in driving organizational change, with a focus on minimizing resistance and optimizing adoption.
• Software Proficiency: Familiarity with Quality Management Systems (QMS) and relevant data analysis tools.
• Workload Prioritization: Ability to organize workload and responsibilities based on critical deadlines and priorities in order to most effectively manage time, utilize resources and achieve results.

Level of Experience:

• Minimum of 10 years of experience in a similar role within medical device manufacturing or a related industry.
• Demonstrated evidence of a solid background of technical knowledge and experience combined with the proven ability to successfully direct people and projects.
• Proven experience in product and process verification and validation.
• Bilingual English / Spanish.
• Willingness to travel between manufacturing sites (50% travel required).

Level of Education:

• Bachelor’s degree in Engineering (preferred); a Master’s degree is a plus.

Travel:

• Ability to travel 50% of time
• Valid passport required

ESSENTIAL DUTIES AND RESPONSIBILITIES

The core tasks, duties, and responsibilities that must be performed on the job.

• Manage the Quality and Compliance Management System across multiple sites to ensure compliance with industry regulations and company standards.
• Standardize and optimize processes and organizational structures best practices across all plants, ensuring consistency and quality performance.
• Conduct Quality systems assessments to identify opportunities and develop action plans on the manufacturing facilities driving continuous improvement.
• Ensure compliance with relevant medical industry regulations and standards, including customer-specific requirements.
• Develop, lead and coordinate implementation plans and participate in projects to ensure quality systems objectives are met, while supporting business needs.
• Establish a management plan for addressing critical quality defects at manufacturing Plants.
• Collaborate with cross-functional teams to drive continuous improvement initiatives.
• Selects, develops, coaches and evaluates personnel to ensure the efficient operation of the function and systems development.
• Provide leadership in budget development and evaluates personnel, objectives, strategic policies, and work plans to ensure effective implementation of business initiatives.
• Lead quality audits and manage corrective actions to maintain compliance.
• Develop and maintain strong networks across AirLife with appropriate teams so that quality best practices can be developed, shared and implemented effectively.
• Travel to manufacturing sites as needed (50% of the time).

OTHER RESPONSIBILITIES

• Capable to step in and provide indirect leadership for a multitude of functions within the Quality organization.
• Focus on achieving our Company mission.
• Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.
• Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
• Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
• Contribute to building and maintaining a positive team environment.
• Assure all policies and guidelines are implemented and followed.

QUALITY POLICY

At AirLife, Quality is our promise. It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.

DEIA STATEMENT

At AirLife, we are committed to building a diverse workforce and an inclusive workplace that reflects the communities and customers we serve. We believe our philosophy on Diversity, Equity, Inclusion, and Advancement (DEIA) encourages excellence and equips us to serve an evolving global marketplace.