What are the responsibilities and job description for the Quality Control Inspector (PHX) position at SunMed Group Holdings, LLC dba AirLife?
COMPANY 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 helped 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 play a crucial role in supporting the Quality and Operations teams by conducting routine quality activities to ensure product quality. This position requires a detail-oriented individual with strong analytical skills and a commitment to maintaining high-quality standards in the production of medical devices. The ideal candidate will have experience in quality control processes and a thorough understanding of regulatory requirements in the medical device industry.
POSITION QUALIFICATIONS
Required Qualifications
- Minimum of 1-3 years of experience in a quality control role, preferably within the medical device or regulated industry.
- Proficiency in basic computer skills, including Microsoft Word and Excel.
- Proven analytical and problem-solving skills.
- Excellent organizational, communication, and planning skills.
- Ability to maintain effective working relationships with teammates and co-workers.
- Experience with a variety of measurement tools (e.g., calipers, micrometers, pressure gauges, ring and plug gauges) and techniques.
- Familiarity with technical drawings and specifications.
- Experience with inspection/test records and Device History Records (DHRs) preferred.
- Medical device or regulated industry experience preferred.
- Travel: none required
ESSENTIAL DUTIES AND RESPONSIBILITIES
The core tasks, duties, and responsibilities that must be performed on the job.
- Perform product inspections against engineering drawings and instructions.
- Determine sampling sizes based on provided criteria.
- Prioritize workload as directed by management.
- Control quarantined products and label rejected/in-process products.
- Document inspection results electronically or on paper, as required, following Good Documentation Practices (GDP).
- Support product investigations, including sorts or reworks, where required, and complete all accompanying documentation. Initiate and manage quality files and records, including nonconforming material reports.
- Review receiving and quality documentation for completeness and accuracy.
- Identify and properly use a 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 and corrective actions to Engineering/Production.
- Support product returns and Investigations.
- Complete tasks with minimal oversight, act with honesty and integrity, and perform other duties as directed.
OTHER RESPONSIBILITIES
Furthermore, the Quality Control Inspector will focus on achieving the company's mission, demonstrate accuracy and thoroughness in daily work, and look for ways to improve and promote quality and safety. They will inspire the trust of others, treat people with respect and dignity, and embrace the value of diversity. Efficient use of time, performing the job accurately and thoroughly, and conserving company resources to improve profits are also essential. The inspector will contribute to building and maintaining a positive team environment and ensure that 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.
