Associate Manager, Quality Engineering

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. 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.

About the role

Position Summary A Quality Engineering Associate Manager leads activities for quality assurance of product design, by ensuring the regulatory and quality processes for compliance are adhered to. This position is a leader who is responsible for overseeing a group of quality professionals, providing direction on daily activities surrounding sustainment, post market feedback, and continuous improvement. In this role, the leader is expected to partner with cross functional departments to ensure priorities are aligned and to drive communication on opportunities for product development.

Qualifications

• Knowledge: ISO-13485, Design Controls, Risk Management, Root Cause Analysis, Complaint Handling / Post Market Feedback
• Level Of Experience: A minimum of 5 years in Quality or Design Engineering roles or Leadership with experience in an FDA regulated and/or ISO certified organization (preferably Medical Device, ISO 13485)
• Level Of Education: Minimum of a bachelor’s degree in engineering

Travel 10-15% Travel Expected; ~2-3 trips per year.

Skills

• Strong interpersonal skills, including effective verbal and written communication
• Ability to interact effectively with functions of a global organization to achieve goals
• Demonstrated ability in prioritizing and completing projects with cross-functional teams
• Ability to mentor and lead technically competent teams
• Thorough understanding of quality control standards and methodologies
• Analytical problem-solving skills
• Demonstrated objectivity and KPI driven acumen
• Proficient with Microsoft Office Suite or related software
• Passion for exploring new and groundbreaking processes
• Ability to make informed decisions under pressure
• Ability to monitor and analyze complaint data and leading root cause corrective actions

Responsibilities

• Line Manager Duties: Provide clear direction, coaching, and performance management to support team development and achievement of AirLife goals
• Line Manager Duties: Align team’s objectives with AirLife priorities, ensuring compliance, promoting a culture of accountability, and upholding AirLife values
• Line Manager Duties: Take accountability and ownership for actively participating in recruitment processes and supporting fair treatment in disciplinary processes for your team
• Line Manager Duties: Drive continuous improvement by fostering innovation, operational excellence, and adoption of best practices within the team
• Line Manager Duties: Champion employee engagement, inclusion, and career development through regular check-ins, talent reviews, and succession planning
• Line Manager Duties: Manage your team’s budget responsibly and exhibit financial accountability
• Individual Contributor Duties - Customer First: Represent the customer internally to AirLife for product and service opportunities
• Individual Contributor Duties - Customer First: Seek to understand customer feedback and ensure responsiveness and service is provided
• Individual Contributor Duties - Leadership: Lead a small team of quality engineers focused on a subset of the AirLife product portfolio or a team of subject matter experts of product quality processes
• Individual Contributor Duties - Leadership: Provide mentorship and direction to the team to include performance feedback and management
• Individual Contributor Duties - Accountability: Represent quality assurance for AirLife and the customer with a sense of urgency and