Quality Systems Coordinator

Quality Systems Coordinator

Company deEscrituraion
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!

General deEscrituraion

Responsible for managing and ensuring the Quality Management System, ensuring compliance with the rules and regulations applicable to the medical industry and AirLife customers, developing, documents, and trains updates or changes in applicable regulations, MDSAP and ISO13485.

Responsible for leading internal, external and client audits, following up on the results of these. 

Specific deEscrituraion

Document Control & Quality System:

• Verify each document change ensuring that document changes or registrations do not affect compliance with applicable MDSAP and ISO 13485 regulations.

• Ensure documentation risk management, being updated in coordination with remediation activities, and interacting with project team members including engineers, regulator, marketing, and production.

• Evaluate procedures within the quality system to identify areas for improvement.

• Participate in meetings for department goals and objectives

• Support to new project requirements such as validations and participation in validation process, ensuring compliance with regulatory requirements.

• Support for the updating of risk analyses, updating and monitoring of applicable metrics.

• Ensure products comply with regulatory requirements including FDA 21cfr part 820 quality system requirements and internal procedures

• Review legal and regulatory requirements to ensure that applicable changes do not affect system requirements.

• Monitoring of the validity of certificates necessary for the organization and management of compliance with these

Internal Audits:

• Coordinate internal audits of documents of each process and follow up on preventive and corrective actions and opportunities for improvement derived from them.

• Perform process audit, to identify daily compliance with the quality management system.

• Perform random audits of DHR, to identify good practices in documentation.

External Audits:

• Coordinate customers, MDSAP and ISO13485 audits, and follow up on preventive and corrective actions and opportunities for improvement derived from them.

• Lead improvements and performance of the quality system.

• Monitor, follow-up and closure of corrective actions of NC derived from audits, internal and external.

Job competency

• Bachelor’s degree, minimum 3 years’ experience in similar position, master’s degree is a plus

• Conversational English (preferred) 80% Minimum

• Knowledge of ISO 13485, MDSAP, Solving Methodologies Tools (8D's / 7 TOOLS / 5 S's), and Quality Management Systems

• Good communications skills

• High service level and teamwork attitude, good judgement with sense of responsibility, initiative, and integrity

• Team player with creative, can-do attitude.

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 with 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.