- Experience with a variety of measurement tools (e.g. calipers, micrometers, pressure gauges, ring and plug gauges, etc.) and techniques required.
- Medical Device or Regulated Industry Experience Preferred
- Familiarity with Device History Records (DHRs) Preferred
- Basic Word and Excel computer skills
- Proven analytical and problem solving skills.
- Excellent organizational, communication, and planning skills
- Ability to maintain a good working relationship with co-workers and the general public
- Minimum of two years experience in manufacturing or quality environment
- High school diploma or equivalent required
- Perform product inspections against engineering drawings and inspection instructions
- Determine appropriate sampling sizes based on provided criteria
- Support prioritization of work load based on business needs, as directed by management
- Ensure control of quarantined product and ensure proper labeling of all rejected or in-process product
- Document inspection results electronically or on paper, as required
- Support product investigations, including sorts or reworks, where required, and complete all accompanying documentation
- Open, edit, and manage quality files, including nonconforming material reports
- Review receiving and quality documentation, including certificates of conformance, certificates of analysis, packing slips, purchase orders, sterilization records and device history records for completeness and accuracy
- Identify and properly use variety of calibrated tools and equipment for the purpose of product testing and inspection
- Monitor calibrated equipment for service and maintenance needs, and help coordinate routine or as-needed product calibration or service
- Provide data, information and corrective action to Engineering/Production, as required
- Perform other duties as directed by your supervisor
- 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.
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Description
Job Description
Job DescriptionCOMPANY 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 Control Inspector will support quality, production, operations, and engineering to conduct routine quality actions related to product quality. This will primarily include inspections of finished goods, investigations of nonconforming materials, supporting management of product inventory, and completing and reviewing all necessary documentation and paperwork, including inspection documentation, sterilization records, and Device History Records (DHRs). This role will also support the management and maintenance of calibrated inspection equipment.
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:
Skills & Abilities:
Level of Experience:
Level of Education:
Travel: None required
ESSENTIAL DUTIES AND RESPONSIBILITIES
The core tasks, duties, and responsibilities that must be performed on the job.
OTHER RESPONSIBILITIES
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.
