Quality Manager (Distribution)

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 Quality Manager, Distribution and Quality Control drives quality assurance and compliance for finished goods manufactured and purchased by AirLife. In this role, the Manager will support the Quality and Regulatory performance requirements for our warehouse and distribution center locations. They will provide leadership and oversite to our Quality Control and Inspection teams, ensuring proper product verification and control prior to customer order fulfilment. They will partner with cross functional departments to support the needs of our customers and to drive the advancement of product quality and control within the company.

This position is a leader who is responsible for overseeing the quality function at our distribution centers, and enforcing the discipline of high-level quality control functions. This position will support our Quality Control and Inspection teams at Phoenix and other Warehouse Locations domestically to ensure consistency and compliance, and lead their teams to ensure adherence to regulatory standards while driving continuous improvement initiatives for quality excellence in AirLife supply chain.

POSITION QUALIFICATIONS

Knowledge:

• Quality Management System Requirements for an ISO 13485-compliant QMS / facility
• Knowledge of quality standards for medical devices (e.g., ISO 13485, FDA QSR, MDSAP, EU Medical Directives, and Canadian Medical Device Regulations).
• Product inventory and management within a warehouse or distribution center setting
• Product Inspection and Acceptance Methodology and Techniques
• Investigation and Root Cause Analysis Techniques
• Audit support experience, for internal/external/customer audits

Skills & Abilities:

• Thorough understanding of quality control standards and methodologies.
• Strong interpersonal skills, including effective verbal and written communication.
• Ability to interact effectively with functions of a global organization to achieve goals.
• Proven leadership skills with demonstrated success directing and completing projects with cross-functional teams.
• Willingness to learn new processes, develop new processes, and make improvements to existing processes.
• Ability to perform duties and manage workload with a high degree of independence.
• Ability to build strong and technically competent teams.
• Ability to make informed decisions under pressure.
• Analytical problem-solving skills.
• Proficient with Microsoft Office Suite or related software.
• Capable of providing coaching and mentorship to your team.
• Excellent verbal and written communication skills.
• Excellent organization skills and attention to detail.
• Strong computer skills: MS Word, MS Excel, PowerPoint, Database Management and Statistical Analysis.

Level of Experience:

• 5-10+ years of Quality Systems or Control Management with leadership experience required.
• Experience working in Medical Device Industry or similar regulated industry required.
• Experience in an FDA regulated and/or ISO certified organization (preferably Medical Device, ISO 13485) preferred.
• Experience in Quality Control or Inspection required.
• Experience with warehouse operations and/or distribution center experience required.
• Familiarity with sterile product and/or processes preferred.
• Experience managing on-site and remote teams preferred.

Level of Education:

• Bachelor's degree in Engineering, Biology, or related field.

Travel:

• Occasional Travel, < 10%

ESSENTIAL DUTIES AND RESPONSIBILITIES

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

• Responsible for Quality Management System and Regulatory Standards compliance at the Phoenix Distribution Center facility.
• Act as a member of the cross-functional site leadership team, driving safety and efficiency initiatives Ensures that the processes necessary for the quality management system are established, implemented, and maintained.
• Ensure proper documentation is developed and maintained for the facility Quality operations, including SOPs/WIs
• Represent the facility during internal and external quality system audits.
• Support pre-audit and post audit activities and facilitate closure of audit findings impacting relevant facilities and processes.
• Responsible for oversite of Quality Inspection Lab and all equipment.
• Manage Quality Control teams at domestic AirLife warehouse / DC facilities.
• Ensure proper execution and maintenance of quality records, include adherence to good documentation practices and proper storage techniques.
• Collaborate with and provide support to manufacturing centers and our finished goods suppliers.
• Reports to upper management on the performance of the quality system and any need for improvement.
• Create, identify, and report on quality metrics.
• Identify areas of opportunity and support continual improvement of the Quality Management System.
• Develop and grow talent for the quality control team in alignment with the company's culture.
• Lead, mentor, and empower a team of quality control leads and inspectors, promoting a collaborative and high-performance culture that focuses on quality, innovation, and professional development.
• Other duties as assigned

OTHER RESPONSIBILITIES

• 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.