Quality Engineer

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

Level of Education

Travel

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

DEIA STATEMENT

BENEFITS

• 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.