Quality Engineer

AirLife; Michigan; On-site; USD 70,000 - 100,000; Full time

Job summary

AirLife is hiring a Quality Engineer to safeguard product quality across design through post-market stages. You will support cross-functional teams in purchasing, production, engineering, and customers with a focus on verification, validation, and risk management.

This role emphasizes CAPA initiation, root-cause analysis, and continuous quality improvements while ensuring compliance with applicable standards and design controls throughout the product lifecycle.

Qualifications

• Experience with AQL inspections, control plans, and drawings interpretation.
• Design controls, risk management, test methods validation, and statistics.
• Familiarity with ISO 13485 and CAPA processes.
• Root cause analysis and problem solving required.
• Strong technical writing and cross-functional collaboration.
• Exposure to FDA/medical device manufacturing is a plus.

Responsibilities

• Support day-to-day product design quality activities and ensure compliance.
• Assist pre/post-production quality engineering for lifecycle development.
• Support validation for tooling, transfers, and new product introductions.
• Investigate nonconformances and customer complaints.
• Initiate and manage CAPAs; drive continuous improvement.
• Interpret specs for production and incoming inspection; assess risk.

Skills

AQL inspection

Design Controls

Risk Management

ISO 13485

Root Cause Analysis

CAPA

Post Market Feedback

Statistical methods

Quality writing

Cross-functional work

Documentation

Analytical thinking

MS Office

Education

B.S. Mechanical/Biomedical/Industrial/Manufacturing Eng

ASQ certification

Tools

Microsoft Office Suite

Job description

Job Description

COMPANY DESCRIPTION

At AirLife, we are dedicated to improving the quality of every breath.Excellence with Every Breathis 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. Ourexpanding 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 cont