Quality Engineer
- 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.
- 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.
- Bachelor’s degree in mechanical, biomedical, industrial, or manufacturing engineering is preferred.
- ASQ certification is preferred.
- 10-15% Travel Expected; 2-3 trips per year.
- 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.
- 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.
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