Quality Systems Manager

Job Description

Job Description

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 Document Control Manager is a key leadership position. The Document Control Manager is responsible and accountable for managing and providing quality oversight to the global electronic Quality Management System (Grand Avenue).

This position will also manage and administer the electronic Quality Management System (Grand Avenue) across sites and acquisitions to ensure compliance to applicable internal procedures, global regulatory requirements, and standards.

This position will be the main resident expert for the following Quality Systems processes : Document and Data Control, Change Control, Training, and Record Management.

This position will lead Quality Systems functions and team at corporate headquarters in Grand Rapids Michigan along with providing support within all AirLife entities related to Document Control activities.

POSITION QUALIFICATIONS

Knowledge :

• Excellent presentation, leadership and team building skills.
• Strong written and oral communication skills, attention to detail, and the ability to prioritize and organize a busy workload.
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment.
• Strong technology skills and abilities, especially with Microsoft Office programs and web-based programs.
• Experience with different electronic document management systems.
• Drives new ideas and innovation to promote process improvement for manual and electronic documentation systems.
• Ability to lead and collaborate with a diverse team (entry level to seasoned) through growth and change.
• Proven experience working in a cross-functional team environment as well as the ability to function independently.
• Proven ability to prioritize and organize a busy and changing workload.
• Ability to create processes and workflows.
• Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies able to do so quickly without sacrificing attention to detail.
• Ideally possess knowledge of the following standards (e.g. ISO 13485, FDA QSR, EU Medical Directives, and Canadian Medical Device Regulations, Japan, Brazil, Australia) and specific regulations and standards affecting Quality Systems.

Level of Experience :

• 5+ years of leadership experience.
• 5+ years of experience in a documentation-related position in a regulated environment.
• Intermediate to advanced working knowledge of medical device regulations and standards (ISO 13485 : 2016, FDA QSR).

Level of Education :

Bachelor’s or associate Degree and / or equivalent work experience.

Travel :

Approximately 2-4 times a year.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• As Document Control Manager, you will lead the development, effective implementation, and continuous improvement activities around Document Management across all AirLife entities and business acquisitions.
• Lead and manage the change control, records management, training, and document and data control processes globally.
• This role functions as the resident expert for Grand Avenues eQMS support on a global scale.
• This position ensures that the Document Control processes are in compliance with FDA regulations, ISO and other regulatory standards.
• Drives continuous improvement to support a sustainable framework for QMS document control activities to enable simplification and standardization.
• Facilitate document translation activities as required.
• Support for regulatory agency inspections and customer audits to be less than 20 per year.
• Ensures Quality Management System Documentation is available and inspection ready at all times.
• Lead and support Grand Avenue eQMS validation activities and any applicable electronic management systems.
• Track, trend, and monitor metrics related to Document Management providing reports as necessary.
• Manages Document Control department activities and in this capacity may be responsible for the supervision of up to 3-6 AirLife employees and / or contract staff.
• Provides leadership, development, mentoring and support for direct reports and / or contractors as well as ongoing resource assessment.

Also responsible for performance management.

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.