Quality Systems Lead

AirLife group

Glendale (AZ)

On-site

USD 32,000 - 45,000

Full time

2 days ago

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Benefits offered by this job

Medical

Dental

Vision

401(k)

Paid time off

Paid holidays

Bereavement leave

Employee assistance

Job summary

AirLife is seeking a Quality Systems Lead to oversee FDA QSR/ISO 13485 compliance and audits. You will organize internal and external audits, maintain audit records, and drive improvements across the QMS.

This role requires strong documentation, communication, and cross-functional collaboration to ensure regulatory and customer requirements are met. The position focuses on maintaining and enhancing quality systems, conducting risk assessments, and mentoring teams to sustain compliance across

Qualifications

ISO13485 Lead Auditor Certificate preferred.
Minimum 5-7 years of Quality System experience in an FDA regulated and/or ISO certified facility.
Occasional travel up to 25%.

Responsibilities

Develop and manage Internal Audit Plans.
Coordinate internal audit activities and schedule.
Lead external audits with notified bodies and customers.
Maintain Audit Management Module in eQMS Grand Avenue and closure of internal audits.
Own audit metrics, reporting, and trending.

Skills

Auditing principles

Communication

Organizational skills

Problem solving

Computer skills

Education

Bachelor/Associate degree

Tools

MS Word

MS Excel

PowerPoint

Database management

Statistical analysis

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Quality Systems Lead

Quality Full Time

2 days ago Requisition ID: 1950

Salary Range: MX$603,741.00 To MX$845,238.00 Annually

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

The Quality Systems Lead is responsible for the overall quality systems compliance with FDA Quality System Requirements, ISO 13485 standard and other country specific applicable requirements. The Quality Systems Lead is responsible for organizing and managing internal audits according to audit plans and coordinating external audits with notified bodies and customers. The responsibilities include overseeing the process of audits, making recommendations on policies, and ensuring that the organization fulfills international and governmental obligations.

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:

In depth industry knowledge regarding best practices, policies, current regulations.
Knowledge of quality standards for medical devices (e.g. ISO 13485, FDA QSR, EU Medical Directives, and Canadian Medical Device Regulations and other country specific requirements.
ISO13485 Lead Auditor Certificate preferred through accredited organization

Skills & Abilities:

Thorough knowledge of the auditing principles and practices
Excellent oral and written communication skills.
Excellent organizational skills and attention to detail.
Ability to develop and maintain positive working relationships with the clients and the employees within an organization
Sound, systematic problem-solving skills.
Strong computer skills: MS Word, MS Excel (charting), PowerPoint, Database Management and Statistical Analysis.

Level of Experience:

Minimum of 5-7 years of Quality System experience in an FDA regulated and/or ISO certified facility (preferably ISO 13485).

Level of Education:

Bachelor/Associate degree or equivalent work experience.

Travel:

Occasional overnight travel (up to 25%).

ESSENTIAL DUTIES AND RESPONSIBILITIES

Manage the Internal Audit Program
- Develop annual Internal Audit Plans.
- Coordinate internal audit activities: Communicate with lead auditors, monitor audit schedule to plan, participate in opening and closing meetings, conduct facility walk throughs.
- Support conducting internal audits.
- Maintain the Audit Management Module in eQMS Grand Avenue and closure of internal audits.
- Maintain and execute on the OFI list from Internal Audits
Manage the External Audit Program
- Coordinate external audit activities: communicating with notified bodies and customers on audit dates, support in travel plans with outside auditors, host auditors onsite, lead the audits, prepare documentation and SMEs for audits, conduct facility walk throughs.
- Coordinate and conduct AirLife Overview presentation and keep up to date opening meeting presentations per applicable site.
- Own audit metrics, reporting, and trending.
- Manage audit performance communication to leadership.
- Maintain and execute the OFI External Audits List.
Support customer requests regarding the QMS. Requests to include self-assessments, surveys, certificate requests, etc.
Develop corporate policies and procedures according to regulatory requirements.
Develop process improvements to improve quality and effectiveness of deliverables.
Review and recommend improvements to business procedures and internal controls.
Develop standard tools and procedures to improve audit efficiency.
Organize audit training for team for skill development.
SME for Audit Intelligence and latest developments in the field; Prepare and conduct studies and reports.
Review audit findings and develop action plans.
Develop clear and complete reports of audit procedures and findings.
Develop risk models to access and mitigate potential risks.
Interact with management to determine audit requirements.
Identify areas of improvement and concerns to management.
Liaison between Regulatory and Notified bodies.

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.

AirLife offers a comprehensive benefits package, including: