CAPA 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. 

POSITION SUMMARY

This position is focused on product 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 non-conformance issues. In addition, this position will drive continuous improvement in quality 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 service, education, or training.

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

• Corrective Action and Preventative Action 
• Root Cause Analysis
• ISO 13485
• Risk Management
• Complaint Handling / Post Market Feedback
• 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. 

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 train others as the CAPA SME.
• 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.

Level of Experience:  

• 2 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’s degree in mechanical, biomedical, industrial, or manufacturing engineering is preferred.
• ASQ certification is preferred. 

Travel:

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

ESSENTIAL DUTIES AND RESPONSIBILITIES

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

• Corporate process owner for CAPAs
• CAPA Quality Engineer working with the CAPA owners and the stakeholders through the entire CAPA process.
• Support all AirLife sites (including manufacturing) CAPAs on the investigation to root cause, plan and implementation of corrective and preventative actions, and verification of effectiveness.
• Lead Corrective Action Review Board for all sites, driving accountability, visibility, and compliance to requirements. 
• Ensure all CAPA phases are closed on time with the highest quality.
• Facilitate the investigation process to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance.
• Create Quality Metrics and presentations for Quality Trend Meeting, Management Review, and CAPA Review Board.
• Work with Subject Matter Experts (SME) on the simplification of CAPA process within the Quality System.
• Initiate continuous improvement projects for product quality through the use of 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 with process improvements. 
• Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits, as per ISO 13485.    
• Drive communication on the performance of the CAPA system with AirLife leadership, ensuring discipline to the process and continuous improvement to the program. 

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.