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 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.

POSITION QUALIFICATIONS

Knowledge, Skills, & Abilities:

• Understanding and experience in AQL inspection, control plans and interpretation of spec and drawings.
• Design Controls and Risk Management: Experience in product verification and validation, test method validation, Statistics, Risk Management Tools
• ISO 13485
• Corrective Action and Preventative Action
• Root Cause Analysis
• 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.
• 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.
• 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.
• Experience in continuous improvement is preferred.
• Exposure to the FDA, medical device or medical manufacturing is a strong plus.
• Experience in quality management systems is a plus.

Level of Education:

• 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

• 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.

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