Quality Engineer

Quality Engineer Position

The Quality Engineer position is focused on ensuring product quality and compliance through the entire product lifecycle, from design through post-market activities. This position supports cross-functional teams including Purchasing, Suppliers, Incoming Inspection, Production, Engineering, and Customers through a strong focus on verification and validation activities to ensure product meets its performance, functionality and intended use requirements. This position leads and supports risk analysis activities to effectively implement risk mitigations and control measures in accordance with applicable standards. Additionally, this position interprets, defines, and develops product quality requirements and ensures testing meets all quality standards. It is also responsible for identifying, analyzing, troubleshooting, and resolving non-conformance issues. In addition, this position will drive continuous improvement in quality processes.

Support day-to-day product design quality related activities. Ensuring these activities are compliant to AirLife's internal processes including design control requirements.

Support pre & post-production design assurance/quality engineering activities as they relate to product lifecycle development.

Support engineering feasibility testing and analysis.

Investigate product nonconformances (NCMRs) and customer complaints.

Initiate and manage Corrective Actions and Preventative Actions (CAPAs)

Support validation activities for new tooling, manufacturing transfers, and new product introductions, as needed.

Interpret specifications and requirements for Production and Incoming Inspection.

Perform Product Risk Assessment and manage risk management files

Initiate continuous improvement projects for product quality using data analytics.

Collaborate with Sustainment Engineering, New Product Development, Sales, and Marketing on new opportunities and product improvements.

Support the management of the Quality System.

Support internal and external quality system audits, as per ISO 13485.

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.

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.

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.

AirLife offers a comprehensive benefits package, including medical, dental, and vision coverage, 401(k), paid time off, paid holidays, bereavement leave, Employee Assistance Program resources, and medical leave benefits, subject to applicable eligibility requirements. Certain positions may also be eligible for bonus, commission, or other incentive compensation.