Supplier Quality Engineer

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 Supplier Quality Engineer is responsible for ensuring the quality and compliance of all externally sourced components, materials, and finished goods for AirLife. This role owns the supplier assessment and approval process, ensuring proper documentation, certifications, and evaluations are maintained in alignment with AirLife procedures and ISO-13485 requirements. The Supplier Quality Engineer drives continuous improvement in supplier performance through technical support, routine monitoring, corrective actions, and supplier development initiatives.

This position leads supplier audits, manages Supplier Corrective Action Requests (SCARs), and supports investigations related to supplier nonconformances. It also plays a key role in reviewing and executing supplier-initiated change requests, ensuring appropriate validations and design verification activities are completed. The role develops acceptance criteria for purchased products to ensure design and regulatory requirements are met and collaborates cross-functionally with Engineering, Sourcing, Sales, Marketing, and New Product Development teams.

POSITION QUALIFICATIONS

Knowledge, Skills, & Abilities:

• ISO-13485
• ASQ Certification is preferred.
• Lead Auditor Certification is preferred.

Level of Experience:

• 1-3 years experience in quality manufacturing, supplier development, or process engineering experience.

Level of Education:

• A minimum B.S. in mechanical, biomedical, industrial, or manufacturing engineering is preferred.

Travel:

Up to 20-25% travel as the business needs.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Owns the assessment and approval of suppliers, along with assurance of proper documentation, certifications, and assessment in alignment with AirLife procedures.
• Drives improvement in the quality of components and finished goods sourced from outside suppliers.
• Provides technical support in the selection of suppliers and manufacturing processes.
• Monitors supplier performance via annual evaluations and monthly scorecards to drive supplier development.
• Initiates and manages Supplier Corrective Actions (SCARs).
• Supports nonconformance investigations for supplier related issues identified through inspection or complaints.
• Supports the review and execution of supplier-initiated change requests, including assurance of validations and design verification activities.
• Serves as lead auditor for supplier audits in compliance to ISO-13485.
• Conducts assessments and provides input to support the integration activities of AirLife.
• Supports the review and execution of supplier-initiated change requests, including assurance of validations and design verification activities.
• Develops acceptance criteria for purchased components and finished goods that demonstrate supplier capability while in alignment with design requirements.
• Collaborates with Sustainment Engineering, New Product Development, Sales, and Marketing on new opportunities and product improvements.
• Leads activities for the qualification of OEM devices and the supplier selection for NPD.
• Drives the strategic roadmap of supplier development in partnership with sourcing and engineering.

OTHER RESPONSIBILITIES

• Uphold and embody AirLife's values in all aspects of work.
• 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.

Please note: The responsibilities outlined above are not exhaustive and may evolve over time. The role holder may be required to undertake additional duties as reasonably expected to meet the needs of the company.