Sterilization Specialist

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 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

This position will lead and execute the sterilization validation and environmental monitoring activities required to maintain compliance to the required ISO standards and internal procedures.

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:

• Knowledgeable of FDA and ISO guidelines for the sterilization assessment of medical devices required.

• Working knowledge of terminal sterilization methods (ISO 11135, ISO 11137, etc) required.

Skills & Abilities:

• Proficiency in the use of Personal Computers and computer programs, particularly the Microsoft Office Suite; Excel, Word, PowerPoint (or equivalents if changed by the Company)

• Ability to define problems, identify opportunities, collect data, analyze established facts, draw valid conclusions, and implement change

• High attention to detail and efficiency with excellent organizational skills

Level of Experience:

The ideal candidate will have 2-5 years of experience in engineering, quality, or manufacturing of sterile products in the medical device field.

Level of Education:

Bachelor’s degree in biomedical engineering or a related field is preferred.

Travel:

Up to 25% Travel may be required, as needed.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The core tasks, duties, and responsibilities that must be performed on the job.

• Maintain sterilization and end-user reprocessing projects, validations, and monitoring program in accordance with Quality Systems Requirements
• Ensure corporate sterilization programs are maintained in accordance with all relevant international standards, e.g., ISO 11135, ISO 11137, ISO 17665, etc. as well as domestic and foreign regulatory requirements
• Coordinate all activities related to validations and/or testing, and directly interact with external and corporate laboratories, and sterilizers personnel to accomplish the assigned tasks
• Perform documented assessments, and validations as required of product and process changes for impact to sterilization process efficacy
• Ensure proper maintenance of files demonstrating internal and vendor compliance and performance including authoring and/or reviewing sterilization validations and product assessments into existing cycles, routine product and environment monitoring reports, non-conformances, CAPA’s, etc.
• Support manufacturing organizations in defining requirements for and ensuring infrastructure systems are efficacious in controlling and preventing potential contamination from device contacting materials, utilities, environments, etc.
• Perform and participate in root cause investigations for microbiological and manufacturing nonconformances.
• Develop continuous improvement initiatives within the Sterility Assurance program.

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.