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Form of workCOMPANY 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
Sr. Quality Engineer for the OEM business leads product and manufacturing for OEM customers and relationships under AirLife. This function interprets, defines, and develops product quality requirements and ensures quality assurance to those specifications for design, manufacturing, and supply chain. Role is responsible for identifying risks, defining mitigation measures, and supporting validation and verifications activities. A key part of this role will be the customer partnership and support to ensure understanding of customer and user needs, and to provide service in the product realization process to bring products to market for the OEM business of anesthesia and respiratory products.
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:
- Design Controls
- Risk Management
- Root Cause Analysis
- Statistical Techniques
- Supplier Controls
- ISO-13485
Skills:
- Strong interpersonal skills, including effective verbal and written communication.
- Ability to interact effectively with functions of a global organization to achieve goals.
- Passion for exploring new and groundbreaking processes.
- Ability to make informed decisions under pressure.
- Analytical problem-solving skills.
- Proficient with Microsoft Office Suite or related software.
Level of Experience:
- A minimum of 5-7 years in Quality or Design Engineering roles or Leadership with experience in an FDA regulated and/or ISO certified organization (preferably Medical Device, ISO 13485).
Level of Education:
- Minimum of a bachelor’s degree in engineering.
Travel:
- 20-25% Travel Expected; 4-5 trips per year.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The core tasks, duties, and responsibilities that must be performed on the job.
- Quality Engineer lead for OEM business projects, with responsibilities to shall follow the entire product lifecycle from design and development to post market support.
- Own the creation and review of quality documents supporting OEM products to include risk management, validations, specifications, etc.
- Clearly communicate project status, timelines, and risks regarding OEM and quality assurance.
- Communicate with customers when applicable for projects/activities.
- Coordinate implementation of design and process changes with manufacturing plants.
- Work closely and communicate effectively with Regulatory, Engineering, Marketing, Sales, Supply Chain, and Manufacturing teams to develop/revise product specifications.
- Support the identification and qualification of suppliers for component or finished good manufacturing as applicable.
- Investigate and respond to design nonconformances.
- Initiate and manage Corrective Actions and Preventative Actions (CAPAs)
- Represent and communicate QA issues with sales and customers.
- Lead validation activities for new tooling, manufacturing transfers, and new product introductions.
- Interpret spec and requirements for Production and Incoming Inspection.
- Initiate continuous improvement projects for product quality using data analytics.
- Assure product compliance to all applicable standards, regulations, and internal procedures.
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.
