Senior Quality Engineer

COMPANY DESCRIPTION

At AirLife, we are dedicated to improving the quality of every breath.  Excellence with Every Breath is not just a tagline, but the way we work and take care of our customers.  We have a mindset to evolve, innovate, and grow as 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

This position is focused on product and manufacturing quality and supports Production, Incoming Inspection, Purchasing, Customers, Suppliers and Engineering.   This function interprets, defines, and develops product quality requirements, as needed.  It is also responsible for identifying, analyzing, troubleshooting, and resolving complaints and non-conformance issues.  In addition, this position will drive continuous improvement activities in product quality as well as quality management system processes. 

POSITION QUALIFICATIONS

The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance.   These competencies are generally demonstrated through specific services, education, or training. 

Knowledge: Acquired through education, certifications, training, experience.

• Understanding and experience in AQL inspection, control plans and interpretation of spec and drawings.
• Basic understanding of mechanical engineering concepts.
• Ability to analyze defective products.
• Strong decision-making abilities.
• Demonstrated technical writing skills.
• Proven ability to work across organizational functions.
• Strong ability to multi-task and to manage time.

Level of Experience: 

• Five-Ten years of experience in Quality is highly preferred.
• Exposure to the FDA, medical device or medical manufacturing is a plus.
• Experience in continuous improvement is preferred.
• Experience in quality systems and management is a strong plus.

Level of Education: 

• A Bachelor degree in mechanical, biomedical, industrial or manufacturing engineering is preferred.
• ASQ certification is a plus. 

Travel: 

Approximately 15% including international travel. Travel to China and Mexico is expected.

ESSENTIAL DUTIES AND RESPONSIBILITIES 

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

• Lead day-to-day manufacturing quality and production processes. 
• Investigate and respond to manufacturing and supplier nonconformances.
• Investigate and resolve internal process non-conformances.
• Initiate and manage Corrective Actions and Preventative Actions (CAPAs)
• Represent and communicate QA issues with sales and customers. 
• Lead validation activities for new tooling, manufacturing transfers, and new product introductions. 
• Serve as QA lead for manufacturing transfers to and from the site.
• Interpret spec and requirements for Production and Incoming Inspection.
• Initiate continuous improvement projects for product quality through the use of data analytics.
• Collaborate with Engineering, NPD, Sales, and Marketing on new opportunities and product improvements. 
• Support the management of the Quality System with process improvements.
• Serve as SME for audits and site inspections.  
• Represent AirLife’s quality system in internal and external audits, as per ISO 13485.   

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.